Perform of a Monthly, Reusable, Soft Contact Lens in Participants Who Previously Dropped Out of Contact Lenses

Perform of a Monthly, Reusable, Soft Contact Lens in Participants Who Previously Dropped Out of Contact Lenses | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Perform of a Monthly, Reusable, Soft Contact Lens in Participants Who Previously Dropped Out of Contact Lenses Andrew Pucker, Gina Wesley, Shane Kannarr, Kristopher May, Jason Miller, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7879757/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Purpose To refit contact lens (CL) dropouts who dropped out of CLs because of dryness or discomfort into TOTAL30® (lehfilcon A) monthly, spherical CLs to determine the frequency that they can be comfortably refit into CLs. Methods A 6-month, 4 visit, multi-center study was conducted. Adult, 18- to 40-year-old, past CL wearers who dropped out of CLs within the past 2 years because of discomfort or dryness were enrolled. Participants were required to have no dry eye symptoms (SPEED scores ≤ 3). All participants were then fit in TOTAL30® CLs. The participants were evaluated with the SPEED, a comfort visual analog scale (VAS; 0-100 scale), and a Likert questionnaire. Result This study enrolled 61 participants who had a median (interquartile) age of 28 (7) years (78.7% female). This study had a CL retention rate of 98.4% at 1 month and 65.6% at 6 months. The VAS yielded a median comfort score of 81 (40) at 6 months. The Likert questionnaire found that 80.7% of participants would recommend the CLs to a friend at 6 months. SPEED scores increased statistically post-resuming CL wear (p = 0.0001) at 1 month, yet this symptoms change was unlikely clinically meaningful. Conclusions This study found that previous CL wearers who had dropped out of CLs could be comfortably refit with lehfilcon A monthly silicone hydrogel CLs, with the majority of them continuing to wear the CLs at 6 months. The results suggest that the monthly soft CLs with water gradient technology can be a viable option for many CL dropout suffers. Contact Lens Monthly Discomfort Dropout TOTAL30 lehfilcon A Introduction Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in “episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear.” 1 While CL dropout occurs in about 20% of wearers annually with the top reason for ending CL wear being ocular discomfort, 2 the majority of CL wearers who cease wearing their CLs have a desire to return to wearing CLs, 3 and it is important to give interested patients the opportunity to resume CL wear as it may afford improved quality of life and satisfaction versus those who only wear spectacles. 4 – 6 CLs can specifically offer improved cosmesis and self-perception, especially among patients with high refractive errors, 5–7 and CLs can provide better visual freedom for those with active or physically demanding lifestyles. 8 Thus, providing CL dropouts with an alternative CL option, which may be more comfortable than their past CLs, could be a means for curbing CL dropout and improving the lives of struggling CL wearers. The authors’ recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into a daily deposable CL that 100% of them were still wearing the new CL at 1 month, and 98% of them were still wearing their CLs at 6 months. 9 While these data suggest that a CL dropout can thrive when being refit into a daily disposable CL, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. TOTAL30® CL (lehfilcon A; Alcon, Fort Worth, TX, USA) is a relatively new monthly replacement CL with water gradient surface technology. The lens material incorporates biomimetic properties that allows the lens to mimic the structure of the corneal surface and has been shown to provide a comfortable wearing experience for the full life of the CL and for the full CL wear day. 10 , 11 Therefore, the purpose of this study was to refit CL dropouts who dropped out of CLs because of dryness or discomfort into TOTAL30® monthly, spherical CLs to determine the frequency that they can be comfortably refit into CLs at 1 and 6 months. Methods Participants This was a 6-month, multi-center study was conducted in the United States. The primary outcome was evaluated at 1 month. One month was the primary outcome timepoint because Young et al. found that most participants who dropped out of CLs in their study dropped out by 1 month (23% dropout). 3 The study was approved by the Southern College of Optometry’s Institutional Review Board (IRB), and it complied with the Declaration of Helsinki. This study was registered with ClinicalTrials.gov (NCT06967298). Adult, 18- to 40-year-old, past CL wearers who had a best corrected visual acuity of 0.00 logarithm of the minimum angle of resolution (logMAR) or better were recruited (Snellen equivalent of 20/20). Participants were required to have worn reusable CLs for at least 1 year before they became a CL dropout. Participants over the age of 40 years were excluded to avoid presbyopia-related vision issues. All participants were required to have dropped out of CLs within the past 2 years because of discomfort or dryness (self-report). 9 This determination was made by listing Young et al.’s reasons for dropping out of CLs and asking the participants to indicate their top reason. 3 Participants were considered a CL dropout if they have not worn CLs in the past 3 months. Participants were required to have scores of ≤ 3 on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (no significant dry eye symptoms). 12 The SPEED was selected because it has been validated in both CL and non-CL wearers. 13 A full list of inclusion and exclusion criteria can be found in Table 1 . Table 1 Study Inclusion and Exclusion Criteria Inclusion Criteria Exclusion Criteria 1. Adults, 18- to 40-year-old, past contact lens wearers who have best corrected 20/20 visual acuity or better 2. Participants were required to have worn reusable contact lenses for at least one year in the past before dropping out of contact lenses 3. Participants over the age of 40 years were excluded to avoid presbyopia-related vision issues 4. Participants must have dropped out of reusable contact lenses within the past two years because of discomfort or dryness 5. Participants were considered a contact lens dropout if they have not worn contact lenses in the past 3 months 6. Participants were required to have scores of ≤ 3 on the Standard Patient Evaluation of Eye Dryness (SPEED) questionaries (no significant dry eye symptoms) 7. Participants were required to be able to wear TOTAL30® sphere contact lens (astigmatism ≤ 0.75 D). 8. Participants were required to provide a prescription for glasses that was less than 3 years old 1. Past rigid contact lens wearers 2. Have a history of being diagnosed with dry eye or ocular allergies 3. Have known systemic health conditions that are thought to alter tear film physiology 4. Have a history of viral eye disease 5. Have a history of ocular surgery 6. Have a history of severe ocular trauma 7. Have a history of corneal dystrophies or degenerations 8. Have active ocular infection or inflammation 9. Are currently using isotretinoin-derivatives or ocular medications 10. Pregnant or breast feeding Clinical Testing After reporting to the baseline visit, participants were asked to complete the informed consent process after being pre-screened by the investigator with an IRB-approved eligibility survey. All enrolled participants were then screened with the SPEED questionnaire to understand their initial eye comfort (scores ≤ 3 required). 13 All relevant participants demographics were collected via a questionnaire developed by the investigators (age, sex, race, ethnicity). Participants were then asked to complete a manifest refraction with binocular balance where the investigator determined the participants’ refractive error with a phoropter and best-corrected visual acuity with a high contrast Bailey-Lovie logMAR chart. No more than 1.00 D of sphere was added beyond the initial blur balance starting point. The investigator then used a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior eye structures: eyelashes, eyelids, conjunctiva, and cornea. The participants were then fit into the study CLs. The CLs were evaluated for centration, movement, coverage, and power. CL power adjustments were only be made if they improved visual acuity. CLEAR CARE® PLUS (Alcon, Fort Worth, TX, USA) was dispensed to every participant. Both the study CLs and care system were provided to the participants at no cost for the duration of the study. Participants were then asked to return to clinic 1 week later for an initial compliance and safety check. Participants were evaluated with SPEED questionnaire, and their high contrast visual acuity while wearing the study CLs was evaluated. The investigator then used a slit-lamp biomicroscope to assess ocular health as described above. The study CLs were evaluated for centration, movement, and coverage, and CL power adjustments were only made if they improve visual acuity. If a participant needed a CL adjustment, they were required to wait a full month before their 1-month follow up visit. Participants were then asked to report for a visit that was schedule about 1 month after they started wearing the study CL. During the 1-month follow-up visit, participants were asked to complete the SPEED questionnaire, a slit-lamp biomicroscope exam, and a CL evaluation as described above, and they were also asked to complete series of investigator-developed questions to evaluate the CL wearing experience. The questionnaire included both Likert questions as well as a visual analog scale (VAS) question that used a 0-100 scale where 100 represented the best possible comfort, 0 represented worst possible comfort, and 50 represented neutral. 10 The participants were then compensated for their time, and they were released from the clinical segment of the study. Participants were later electronically contacted 6 months after the baseline visit, and they were asked the same VAS and Likert questions to determine their long-term CL status. CL retention was defined as participant who were still wearing the CLs at a given timepoint. Sample Size and Statistical Analysis Plan All data were collected with Research Electronic Data Capture (REDCap; Vanderbilt; Nashville, TN, USA), 14, 15 and the data were analyzed with Stata/BE 18 (StataCorp LLC; TX, USA). This study aimed to understanding if CL dropouts could be comfortably refit into TOTAL30® CLs. The primary outcome of this study was the VAS comfort scores at the 1-month visit. This study did not have a formal sample size calculation given the study’s primary outcome was based upon a single arm and was not comparative. Thus, a sample of 60 participants were recruited because it was deemed a reasonable and feasible number of participants who could be recruited over a 6-month period. This number of participants was likewise deemed sufficient to begin to understand the qualitative experience of uncomfortable CL wearers who were being refit into new CLs based upon a past study conducted by the investigators. 9 The data were assumed to be non-normally distributed; therefore, continuous variables were summarized with medians with interquartile ranges (IQR) while categorical results are summarized as percentages. Kruskal–Wallis tests were used to compare continuous variables across the life of the study. Comparisons were considered significant at p < 0.05. Results This study enrolled 61 participants who had a median (IQR) age of 28 (7) years, and 78.7% of the participants were female. The participants identified as Asian (16.4%), Black or African American (9.8%), White (67.2%), More than One Race (4.9%), or Unknown or Not Reported (1.6%) with 1.6% of the participants identifying as Hispanic. Only 1 participant was lost to follow up before the 1-month visit, and only 2 additional participants were lost to follow at 6 months. The participants had a median (IQR) refractive error (sphere/cylinder power) in their right eyes of -1.50 D (2.50 D)/-0.50 D (0.50 D) and − 1.75 D (2.75 D)/-0.50 D (0.50 D) in their left eyes. The participants had right and left eye baseline, best-corrected visual acuities of 0.00 (0.10) logMAR and 0.00 (0.10) logMAR, respectively. The participants had finalized CL powers of -1.75 D (2.25 D) and − 2.00 D (2.25 D) in their right and left eyes, respectively, at baseline, and only one participant required a CL power change of 0.25 D at the 1-week visit in one eye. The participants had right and left eye baseline CL visual acuities of 0.00 (0.10) logMAR and 0.00 (0.10) logMAR, respectively. Visual acuity with CL did not significantly change over the course of the study (all p ≥ 0.64). None of the participants self-reported any adverse event, and no adverse events were detected at study visits via the ocular examinations. At 1 month, the participants indicated that they wore their CLs a median of 10.0 (4.0) hours/day over the past week, that they had a median of 8.0 (2.0) hours/day of comfortable wear over the past week, and that they wore their CLs for a median of 5 (2) days over the past week. At 6 months, the participants indicated that they wore their CLs a median of 9.5 (12.0) hours/day over the past week, that they had a median of 6.0 (10.0) hours/day of comfortable wear over the past week, and that they wore their CLs for a median of 4 (6) days over the past week. All the participants that were still in the study at 1 month were wearing the CLs. This resulted in an overall CL retention rate of 98.4% (60/61 participants). However, by 6 months, 18 of the participants who completed the survey were no longer wearing the CLs. This resulted in an overall CL retention rate of 65.6% (40/61 participants). The study’s primary outcome was CL comfort at the 1-month visit as measured with the same questions in two different formats. The first approach used a 0-100 VAS, which yielded comfortable median comfort scores at both the 1-month (85 [15] units) and 6-month (81 [40] units) timepoints. The second approach used the same question in Likert form with 79.3% of participants indicating that they were either very satisfied or satisfied with their CL comfort over the past week, and only 10.4% of the participants indicated that they were either very unsatisfied or unsatisfied with their CL comfort over the past week at 1 month (Table 2 ). These data are supported by the participants having a baseline SPEED score of 2.0 (3.0) with SPEED scores of 3.5 (5.5) and 4.0 (5.5) at the 1-week and 1-month visits, respectively; nevertheless, SPEED scores did get significantly worse post-resuming CL wear (p = 0.0001). This study also found that 43% of participants had comfortable SPEED scores (scores ≤ 3) at 1 month. 12 The participants additionally reported that they were very satisfied or satisfied with their vision (87.1%) and CL comfort at the end of the day (75.4%) over the past week at 1 month. They likewise indicated that they were very likely or likely to continuing wearing their CLs on a daily basis (72.4%) and 87.0% of the participants indicated that they would recommend the study CLs to a friend at 1 month. The participants indicated that they strongly agreed or agreed that they study CLs allowed them to participate in fitness activities more easily (49.4%), allowed them to use digital devices more easily (49.1%), allowed them to more easily be able to complete general daily activities (63.7%), allowed them to feel more self-confident (57.2%), allowed them to feel less eye fatigue (46.8%), allowed them to feel happier (50.7%), and allowed them to feel less eyestrain (52.0%) at 1 month (Table 2 ). Though the 6-month responses generally include slightly fewer top-2-box ratings and a higher proportion of neutral responses, they follow a similar trend to the 1-month data, with significantly more positive response than negative ones (Table 2 ). Table 2 Likert Questionnaire Results Questions 1-Month Visit (n = 60) Frequency of Responses (percent) 6-Month Virtual Survey (n = 58) Frequency of Responses (percent) Overall, how satisfied are you with your vision in your current contact lenses over the past week? Very Satisfied: 48.1% Satisfied: 39.0% Neither Satisfied nor Dissatisfied: 10.4% Unsatisfied: 2.6% Very Unsatisfied: 0.0% Very Satisfied: 37.9% Satisfied: 27.6% Neither Satisfied nor Dissatisfied: 29.3% Unsatisfied: 5.2% Very Unsatisfied: 0.0% Overall, how satisfied are you with the comfort of your current contact lenses at the end of the day over the past week? Very Satisfied: 24.7% Satisfied: 50.7% Neither Satisfied nor Dissatisfied: 13.0% Unsatisfied: 9.1% Very Unsatisfied: 2.6% Very Satisfied: 15.5% Satisfied: 34.5% Neither Satisfied nor Dissatisfied: 37.9% Unsatisfied: 12.1% Very Unsatisfied: 0.0% Overall, how satisfied are you with the comfort of your current contact lenses over the past week? Very Satisfied: 37.7% Satisfied: 41.6% Neither Satisfied nor Dissatisfied: 10.4% Unsatisfied: 9.1% Very Unsatisfied: 1.3% Very Satisfied: 31.6% Satisfied: 28.1% Neither Satisfied nor Dissatisfied: 29.8% Unsatisfied: 10.5% Very Unsatisfied: 0.0% Overall, how likely are you to continue wearing these contact lenses on a daily basis? Very Likely: 31.6% Likely: 40.8% Neither Likely nor Unlikely: 11.8% Unlikely: 11.8% Very Unlikely: 4.0% Very Likely: 19.0% Likely: 32.8% Neither Likely nor Unlikely: 27.6% Unlikely: 15.5% Very Unlikely: 5.2% Would you recommend your current contact lenses to a friend? Yes: 87.0% No: 13.0% Yes: 80.7% No: 19.3% Wearing the study contact lenses has allowed me to participate in fitness activities more easily. Strongly Agree: 23.4% Agree: 26.0% Neither Agree nor Disagree: 42.9% Disagree: 2.6% Strongly Disagree: 2.6% Not Applicable: 2.6% Strongly Agree: 22.4% Agree: 32.8% Neither Agree nor Disagree: 34.5% Disagree: 6.9% Strongly Disagree: 1.7% Not Applicable: 1.7% Wearing the study contact lenses has allowed me to use digital devices more easily. Strongly Agree: 15.6% Agree: 32.5% Neither Agree nor Disagree: 41.6% Disagree: 3.9% Strongly Disagree: 6.5% Not Applicable: 0.0% Strongly Agree: 10.3% Agree: 22.4% Neither Agree nor Disagree: 48.3% Disagree: 13.8% Strongly Disagree: 5.2% Not Applicable: 0.0% Wearing the study contact lenses has allowed me more easily complete my general daily activities. Strongly Agree: 16.9% Agree: 46.8% Neither Agree nor Disagree: 29.9% Disagree: 6.5% Strongly Disagree: 0.0% Strongly Agree: 13.8% Agree: 32.8% Neither Agree nor Disagree: 41.4% Disagree: 12.1% Strongly Disagree: 0.0% Wearing the study contact lenses has allowed me to feel more self-confident. Strongly Agree: 16.9% Agree: 40.3% Neither Agree nor Disagree: 39.0% Disagree: 3.9% Strongly Disagree: 0.0% Strongly Agree: 22.4% Agree: 19.0% Neither Agree nor Disagree: 53.5% Disagree: 5.2% Strongly Disagree: 0.0% Wearing the study contact lenses has allowed me to feel less eye fatigue. Strongly Agree: 11.7% Agree: 35.1% Neither Agree nor Disagree: 32.5% Disagree: 16.9% Strongly Disagree: 3.9% Strongly Agree: 12.1% Agree: 32.8% Neither Agree nor Disagree: 34.5% Disagree: 19.0% Strongly Disagree: 1.7% Wearing the study contact lenses has allowed me to feel happier. Strongly Agree: 13.0% Agree: 37.7% Neither Agree nor Disagree: 39.0% Disagree: 10.4% Strongly Disagree: 0.0% Strongly Agree: 15.5% Agree: 24.1% Neither Agree nor Disagree: 50.0% Disagree: 10.3% Strongly Disagree: 0.0% Wearing the study contact lenses has allowed me to feel less eyestrain. Strongly Agree: 16.9% Agree: 35.1% Neither Agree nor Disagree: 28.6% Disagree: 14.3% Strongly Disagree: 5.2% Strongly Agree: 15.5% Agree: 27.6% Neither Agree nor Disagree: 41.4% Disagree: 13.8% Strongly Disagree: 1.7% Discussion This study is significant because it describes the frequency of past CL wearers who can be comfortably refit into a reusable, daily wear, monthly soft CL. These data are important because they could provide credence for fitting struggling soft CL patients or patients who stopped wearing CLs into an alternative CL, which could help curb the frequency of CL dropout and provide patients an opportunity to continue wearing CLs. This study found that participants could be refit in the study CL with only 3 participants being lost to follow up over this 6-month study and with 79.3% and 59.7% of participants indicating that they were satisfied with their CL comfort over the past week at 1 month and 6 months, respectively. This study likewise found an overall CL retention rate of 98.4% at 1 month and an overall CL retention rate of 65.6% at 6 months. While not every participant in this study was able to achieve comfortable CL wear until when they removed the CLs, this study’s results are exceptionally promising given that all included participants were former CL wearers. It is anecdotally not uncommon for practitioners to defer to daily disposable CLs when managing patients at high risk of dropout or already dropped out. This study suggests that patients who previously discontinued reusable CL wear can be comfortably refit with another monthly CL made of lehfilcon A. CL dropout has been a recognized issue for decades, 16–20 and the frequency of patients electing to stop wearing CLs has unfortunately been stable over this time period even with the advent of optimized CLs materials, daily disposable CLs, and the development of new pharmaceutical agents. 2 , 21 One of the most promising studies related to curbing CL dropout was conducted by Young et al. who refit 236 CL dropouts who dropped out of CL at least 1 year ago into any alternative CL brand that was suitable to the participant’s needs. 3 This study includes a combination of CL materials (silicone hydrogel, hydrogel, rigid gas permeable) and CLdesigns (sphere, toric, bifocal). The authors interestingly found that 77% of participants could be successfully refit into CLs at the 1 month visit and 74% of participant were still wearing the CLs after 6 months. 3 More recently Lievens et al. refit 60 CL dropouts with the same entry criteria as the current study into a single brand of daily disposable CLs (Dailies TOTAL1®, delefilcon A) and found that 100% of participants were able to successfully wear the study CLs for 1 month and all but 1 participant were still wearing the CLs after 6 months. 9 The current study came to a similar result as these past studies with the current study finding that 98.4% of participants were able to wear the study CLs for 1 month, and 65.6% of participants were still wearing the study CLs at 6 months. Nevertheless, the current study found that the monthly CLs wearers in this study were slightly less satisfied with the comfort of the study CLs (75.4 vs. 78.0%) and with the vision in the study CLs (87.1 vs. 93.2%) at 1 month compared to Lievens et al.’s work using delefilcon A daily disposable CLs. 9 A similar trend was also noticed when comparing the 6 month data. The current study likewise found that SPEED scores got significantly worse over the first month after reinitiating CL wear compared to baseline, yet this worsening was unlikely to be at a clinically significant level given that the median changes were only 1.5 to 2.0 units and because SPEED score remained low at 1-month. 12 The likely reason for the difference between the current work and Lievens et al.’s work is that the current study evaluated a monthly, reuseable CL while Lievens et al.’s work evaluated a daily disposable CL. 9 These results suggest that previous soft CL dropouts should be closely monitored during the first 6 months of wear after being refit, particularly when being refit into a monthly CL; and if monthly CL wearers are unhappy, they may benefit from being switched to a different CL or more specifically a daily disposable CL. While this study had several strengths, which include the standardization of offering the same monthly CL, enrolling a robust number of CL dropouts, and evaluating the participant’s CL wearing experience with multiple instruments, this study is not without limitations. Although using a single CL material is a strength in that it provides consistency among participants, it is also a limitation because the study results can only be directly applied to the material and design tested. Therefore, a similar study could be repeated with alternative CL brands and/or designs to make the results more generally applicable. This study likewise only evaluated a single CL replacement schedule, and because of this issue, a future study should be completed and assess how daily disposable and monthly CLs compare with regards to allowing CL dropouts to return to wearing CLs. The last limitation is that this study only evaluated participants who dropped out of CLs because of discomfort or dryness. While these two issues are the most common reasons for ceasing CL wear, the community would benefit from more data to evaluating how refitting patients into CLs who dropped out of CLs for other reasons (e.g., vision, handling). Conclusion This study found that many of the participants who dropped out of CLs because of dryness or discomfort could successfully resume CL wear for at least 6 months with lehfilcon A monthly CLs. This success is supported by the current study determining that 79.3% of the participants were satisfied with their CL comfort and that 87.0% of participants would recommend the CLs to a friend after 1 month of wear. A similar positive result was found at 6 months with the current study determining that 59.7% of the participants were satisfied with their CL comfort and that 80.7% of participants would recommend the CLs to a friend. These data are important because they demonstrate that past CL wearers can resume CL wear if given the opportunity to try a new CL material. Refitting with a novel CL material may benefit CL dropouts or patients at high risk of dropout, without requiring a change in replacement schedule. During the study period, participants reported a median of 6 to 8 hours of comfortable wearing time per day and were able to wear the CLs for a median of 4 to 5 days per week. Nevertheless, when data with the monthly CL in this study are compared to the similar work that evaluated a daily disposable CL, more participants who have a history of CL dropout were satisfied with the CL performance if refit into a daily disposable CLs compared to monthly CLs. 9 While the results of this study are promising, more work is needed to directly determine how CL dropouts would respond to a different brand of CL or CL wear schedule. Declarations Commercial Relationship Disclosures The authors have received research support from Abbvie Pharmaceuticals (ADP, CL, SK), Alcon Research, LLC (All), Allergan (CL, SK), Bausch + Lomb (ADP, CL, SK), and Topcon (ADP, CL, SK). The authors have served as consultants for CooperVision (SK, KM), Bausch + Lomb (ADP, CL, SK), Essilor (CL), HanAll Biopharma (ADP), Luxottica (CL), Mintra Health (ADP), RVL Pharmaceuticals, Inc (CL), and Transitions (CL). Dr. Pucker was an employee of Lexitas Pharma Services during the conduct of this work, and he is the owner of Eminent Ophthalmic Services, LLC; neither company makes nor markets an ophthalmic product. Funding This study was supported with an investigator-initiated study grant from Alcon Vision, LLC, Fort Worth, TX, USA. Author Contribution Authors 1 and 9 conceptualized the project, wrote the manuscript and performed the analysis.Authors 2,3,4,5 enrolled subjects, collected data and reviewed the manuscript.Authors 6 & 7 created the case report forms and managed the data and reviewed the manuscript.Author 8 collected data and contributed to manuscript writing and editing. References Nichols JJ, Willcox MD, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: executive summary. Invest Ophthalmol Vis Sci 2013;54:TFOS7-TFOS13. Pucker AD, Tichenor AA. A Review of Contact Lens Dropout. Clin Optom (Auckl) 2020;12:85–94. Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt 2002;22:516–527. Walline JJ, Jones LA, Sinnott L, et al. Randomized trial of the effect of contact lens wear on self-perception in children. Optom Vis Sci 2009;86:222–232. Guthrie S, Ng A, Woods J, Vega J, Orsborn G, Jones L. Exploring the factors which impact overall satisfaction with single vision contact lenses. Cont Lens Anterior Eye 2022;45:101579. Queiros A, Villa-Collar C, Gutierrez AR, Jorge J, Gonzalez-Meijome JM. Quality of life of myopic subjects with different methods of visual correction using the NEI RQL-42 questionnaire. Eye Cont Lens 2012;38:116–121. Maldonado-Codina C, Navascues-Cornago M, Plowright AJ, et al. Using face masks with spectacles versus contact lenses. Cont Lens Anterior Eye 2022;45:101516. Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology 2003;110:2292–2301. Lievens C, Pucker AD, Rayborn E, et al. Refitting contact lens dropouts into a modern daily disposable contact lens. Ophthalmic Physiol Opt 2024;44:686–692. Call T, Pucker AD, McGwin G, Jr., Franklin QX, Logan A. Real-Time Ocular Comfort Reporting in Monthly Replacement Contact Lens Wearers. Clin Optom (Auckl) 2023;15:97–103. Ishihara K, Shi X, Fukazawa K, Yamaoka T, Yao G, Wu JY. Biomimetic-Engineered Silicone Hydrogel Contact Lens Materials. ACS Appl Bio Mater 2023;6:3600–3616. Asiedu K, Kyei S, Mensah SN, Ocansey S, Abu LS, Kyere EA. Ocular Surface Disease Index (OSDI) Versus the Standard Patient Evaluation of Eye Dryness (SPEED): A Study of a Nonclinical Sample. Cornea 2016;35:175–180. Pucker AD, Dougherty BE, Jones-Jordan LA, Kwan JT, Kunnen CME, Srinivasan S. Psychometric Analysis of the SPEED Questionnaire and CLDEQ-8. Invest Ophthalmol Vis Sci 2018;59:3307–3313. Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform 2019;95:103208. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–381. Weed K, Fonn D, R. P. Discontinuation of contact lens wear. Optom Vis Sci. 1993;70(Suppl):140. S. B. Profile of contact lens failures in Saudi Arabia. Clin Exp Optom 1996;79:255–259. Pritchard N, Fonn D, Brazeau D. Discontinuation of contact lens wear: a survey. Int Contact Lens Clin 1999;26:157–162. Richdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with contact lens dissatisfaction and discontinuation. Cornea 2007;26:168–174. Dumbleton K, Woods CA, Jones LW, Fonn D. The impact of contemporary contact lenses on contact lens discontinuation. Eye Cont Lens 2013;39:93–99. Pucker AD, Derthick N, Scott L. Running the enrollment numbers on ophthalmic clinical trials in the United States. Optom Vis Sci 2024;101:523–529. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 29 Jan, 2026 Reviews received at journal 28 Jan, 2026 Reviewers agreed at journal 10 Dec, 2025 Reviews received at journal 01 Dec, 2025 Reviewers agreed at journal 17 Nov, 2025 Reviewers invited by journal 21 Oct, 2025 Editor assigned by journal 21 Oct, 2025 Submission checks completed at journal 20 Oct, 2025 First submitted to journal 16 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7879757","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":532876139,"identity":"04c552b7-37f8-4ec6-b134-dca3b20dd991","order_by":0,"name":"Andrew Pucker","email":"","orcid":"","institution":"Eminent Ophthalmic Services","correspondingAuthor":false,"prefix":"","firstName":"Andrew","middleName":"","lastName":"Pucker","suffix":""},{"id":532876140,"identity":"656f6762-cf42-4726-9b6c-3bba0245a090","order_by":1,"name":"Gina Wesley","email":"","orcid":"","institution":"Complete Eye Care of Medina","correspondingAuthor":false,"prefix":"","firstName":"Gina","middleName":"","lastName":"Wesley","suffix":""},{"id":532876141,"identity":"8a63424e-48bc-4d8a-a5a3-5d18651aa29b","order_by":2,"name":"Shane Kannarr","email":"","orcid":"","institution":"Kannarr Eye Care","correspondingAuthor":false,"prefix":"","firstName":"Shane","middleName":"","lastName":"Kannarr","suffix":""},{"id":532876142,"identity":"32586ae0-1f9d-4ad3-848e-057b018623eb","order_by":3,"name":"Kristopher May","email":"","orcid":"","institution":"Coldwater Vision Center","correspondingAuthor":false,"prefix":"","firstName":"Kristopher","middleName":"","lastName":"May","suffix":""},{"id":532876143,"identity":"dec2a43d-f9da-4893-be24-b92efc38f31c","order_by":4,"name":"Jason Miller","email":"","orcid":"","institution":"Eyecare Professionals of Powell","correspondingAuthor":false,"prefix":"","firstName":"Jason","middleName":"","lastName":"Miller","suffix":""},{"id":532876144,"identity":"67cec0a9-dce7-46a7-9271-677c81b54332","order_by":5,"name":"Morgan Bromley","email":"","orcid":"","institution":"Southern College of Optometry","correspondingAuthor":false,"prefix":"","firstName":"Morgan","middleName":"","lastName":"Bromley","suffix":""},{"id":532876145,"identity":"4171fb42-7341-4889-9370-9155087ba01b","order_by":6,"name":"Quentin Franklin","email":"","orcid":"","institution":"University of Alabama at Birmingham,","correspondingAuthor":false,"prefix":"","firstName":"Quentin","middleName":"","lastName":"Franklin","suffix":""},{"id":532876146,"identity":"4c5f2c3e-c095-4e03-a20b-a2fe8d51f240","order_by":7,"name":"Elyse Rayborn","email":"","orcid":"","institution":"Southern College of Optometry","correspondingAuthor":false,"prefix":"","firstName":"Elyse","middleName":"","lastName":"Rayborn","suffix":""},{"id":532876147,"identity":"7c6766b9-e32f-4da5-9e8a-9d0e04e09412","order_by":8,"name":"Chris Lievens","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAuElEQVRIiWNgGAWjYDACdsYGMM0P4TIToYUZqkWygXgtUNrgALFa+JuZGx/zVNyxNz5/+OEDhgrrxAZCWiQOMzYb85x5lrjtRpqxAcOZdMJaDJgZ2yRnth1OMLvBwybB2HaYKC3tP2f+O2xv3H8GqOUfcVraGD42HGbcwJAD1NJAhBaQXyQ+HDucOAPkl4Rj6cYEtfC3tz/8kFBz2J6/HxhiH2qsZQlqQQUJpCkfBaNgFIyCUYALAACgCTw9HGMhBAAAAABJRU5ErkJggg==","orcid":"","institution":"Southern College of Optometry","correspondingAuthor":true,"prefix":"","firstName":"Chris","middleName":"","lastName":"Lievens","suffix":""}],"badges":[],"createdAt":"2025-10-16 16:38:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7879757/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7879757/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":94829238,"identity":"37e4c995-c945-45eb-9350-6ea5a55cc708","added_by":"auto","created_at":"2025-10-31 07:07:41","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":96710,"visible":true,"origin":"","legend":"","description":"","filename":"CLDropoutManuscript.docx","url":"https://assets-eu.researchsquare.com/files/rs-7879757/v1/d338359e79333923be8cff8a.docx"},{"id":94829239,"identity":"65aa393e-3313-4596-879d-1980b3515a4b","added_by":"auto","created_at":"2025-10-31 07:07:41","extension":"json","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":9722,"visible":true,"origin":"","legend":"","description":"","filename":"bee4f151398d4e7caaddec43be3e541e.json","url":"https://assets-eu.researchsquare.com/files/rs-7879757/v1/af1ca489b46fa8d26817a32c.json"},{"id":94829237,"identity":"bb6fa8b2-7b64-498c-8673-4c12ba7ea577","added_by":"auto","created_at":"2025-10-31 07:07:41","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":70166,"visible":true,"origin":"","legend":"","description":"","filename":"bee4f151398d4e7caaddec43be3e541e1enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-7879757/v1/e359f18aa45b24ccc8fd8a64.xml"},{"id":94829241,"identity":"1f9bcb68-e4fb-429a-a998-443d76d831cf","added_by":"auto","created_at":"2025-10-31 07:07:41","extension":"xml","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":68780,"visible":true,"origin":"","legend":"","description":"","filename":"bee4f151398d4e7caaddec43be3e541e1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7879757/v1/951d6c945b69c90e8c2a6d20.xml"},{"id":94984761,"identity":"5d9a9f47-0994-461d-b6de-fe4056805245","added_by":"auto","created_at":"2025-11-03 06:56:02","extension":"html","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":75330,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7879757/v1/eb05200261577377d88848de.html"},{"id":95220837,"identity":"6af0ff2f-e160-4b8d-93e7-1ed51bd27ff8","added_by":"auto","created_at":"2025-11-05 16:15:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":635402,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7879757/v1/d08ba740-02fb-4159-9b1b-68ad7f01b661.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Perform of a Monthly, Reusable, Soft Contact Lens in Participants Who Previously Dropped Out of Contact Lenses","fulltext":[{"header":"Introduction","content":"\u003cp\u003eContact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in \u0026ldquo;episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear.\u0026rdquo;\u003csup\u003e1\u003c/sup\u003e While CL dropout occurs in about 20% of wearers annually with the top reason for ending CL wear being ocular discomfort,\u003csup\u003e2\u003c/sup\u003e the majority of CL wearers who cease wearing their CLs have a desire to return to wearing CLs,\u003csup\u003e3\u003c/sup\u003e and it is important to give interested patients the opportunity to resume CL wear as it may afford improved quality of life and satisfaction versus those who only wear spectacles.\u003csup\u003e\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e CLs can specifically offer improved cosmesis and self-perception, especially among patients with high refractive errors,\u003csup\u003e5\u0026ndash;7\u003c/sup\u003e and CLs can provide better visual freedom for those with active or physically demanding lifestyles.\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e Thus, providing CL dropouts with an alternative CL option, which may be more comfortable than their past CLs, could be a means for curbing CL dropout and improving the lives of struggling CL wearers.\u003c/p\u003e\u003cp\u003eThe authors\u0026rsquo; recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into a daily deposable CL that 100% of them were still wearing the new CL at 1 month, and 98% of them were still wearing their CLs at 6 months.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e While these data suggest that a CL dropout can thrive when being refit into a daily disposable CL, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. TOTAL30\u0026reg; CL (lehfilcon A; Alcon, Fort Worth, TX, USA) is a relatively new monthly replacement CL with water gradient surface technology. The lens material incorporates biomimetic properties that allows the lens to mimic the structure of the corneal surface and has been shown to provide a comfortable wearing experience for the full life of the CL and for the full CL wear day.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e Therefore, the purpose of this study was to refit CL dropouts who dropped out of CLs because of dryness or discomfort into TOTAL30\u0026reg; monthly, spherical CLs to determine the frequency that they can be comfortably refit into CLs at 1 and 6 months.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eParticipants\u003c/h2\u003e\u003cp\u003eThis was a 6-month, multi-center study was conducted in the United States. The primary outcome was evaluated at 1 month. One month was the primary outcome timepoint because Young et al. found that most participants who dropped out of CLs in their study dropped out by 1 month (23% dropout).\u003csup\u003e3\u003c/sup\u003e The study was approved by the Southern College of Optometry\u0026rsquo;s Institutional Review Board (IRB), and it complied with the Declaration of Helsinki. This study was registered with ClinicalTrials.gov (NCT06967298). Adult, 18- to 40-year-old, past CL wearers who had a best corrected visual acuity of 0.00 logarithm of the minimum angle of resolution (logMAR) or better were recruited (Snellen equivalent of 20/20). Participants were required to have worn reusable CLs for at least 1 year before they became a CL dropout. Participants over the age of 40 years were excluded to avoid presbyopia-related vision issues. All participants were required to have dropped out of CLs within the past 2 years because of discomfort or dryness (self-report).\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e This determination was made by listing Young et al.\u0026rsquo;s reasons for dropping out of CLs and asking the participants to indicate their top reason.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e Participants were considered a CL dropout if they have not worn CLs in the past 3 months. Participants were required to have scores of \u0026le;\u0026thinsp;3 on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (no significant dry eye symptoms).\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e The SPEED was selected because it has been validated in both CL and non-CL wearers.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e A full list of inclusion and exclusion criteria can be found in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eStudy Inclusion and Exclusion Criteria\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInclusion Criteria\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eExclusion Criteria\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1. Adults, 18- to 40-year-old, past contact lens wearers who have best corrected 20/20 visual acuity or better\u003c/p\u003e\u003cp\u003e2. Participants were required to have worn reusable contact lenses for at least one year in the past before dropping out of contact lenses\u003c/p\u003e\u003cp\u003e3. Participants over the age of 40 years were excluded to avoid presbyopia-related vision issues\u003c/p\u003e\u003cp\u003e4. Participants must have dropped out of reusable contact lenses within the past two years because of discomfort or dryness\u003c/p\u003e\u003cp\u003e5. Participants were considered a contact lens dropout if they have not worn contact lenses in the past 3 months\u003c/p\u003e\u003cp\u003e6. Participants were required to have scores of \u0026le;\u0026thinsp;3 on the Standard Patient Evaluation of Eye Dryness (SPEED) questionaries (no significant dry eye symptoms)\u003c/p\u003e\u003cp\u003e7. Participants were required to be able to wear TOTAL30\u0026reg; sphere contact lens (astigmatism\u0026thinsp;\u0026le;\u0026thinsp;0.75 D).\u003c/p\u003e\u003cp\u003e8. Participants were required to provide a prescription for glasses that was less than 3 years old\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1. Past rigid contact lens wearers\u003c/p\u003e\u003cp\u003e2. Have a history of being diagnosed with dry eye or ocular allergies\u003c/p\u003e\u003cp\u003e3. Have known systemic health conditions that are thought to alter tear film physiology\u003c/p\u003e\u003cp\u003e4. Have a history of viral eye disease\u003c/p\u003e\u003cp\u003e5. Have a history of ocular surgery\u003c/p\u003e\u003cp\u003e6. Have a history of severe ocular trauma\u003c/p\u003e\u003cp\u003e7. Have a history of corneal dystrophies or degenerations\u003c/p\u003e\u003cp\u003e8. Have active ocular infection or inflammation\u003c/p\u003e\u003cp\u003e9. Are currently using isotretinoin-derivatives or ocular medications\u003c/p\u003e\u003cp\u003e10. Pregnant or breast feeding\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eClinical Testing\u003c/h3\u003e\n\u003cp\u003eAfter reporting to the baseline visit, participants were asked to complete the informed consent process after being pre-screened by the investigator with an IRB-approved eligibility survey. All enrolled participants were then screened with the SPEED questionnaire to understand their initial eye comfort (scores\u0026thinsp;\u0026le;\u0026thinsp;3 required).\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e All relevant participants demographics were collected via a questionnaire developed by the investigators (age, sex, race, ethnicity). Participants were then asked to complete a manifest refraction with binocular balance where the investigator determined the participants\u0026rsquo; refractive error with a phoropter and best-corrected visual acuity with a high contrast Bailey-Lovie logMAR chart. No more than 1.00 D of sphere was added beyond the initial blur balance starting point. The investigator then used a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior eye structures: eyelashes, eyelids, conjunctiva, and cornea. The participants were then fit into the study CLs. The CLs were evaluated for centration, movement, coverage, and power. CL power adjustments were only be made if they improved visual acuity. CLEAR CARE\u0026reg; PLUS (Alcon, Fort Worth, TX, USA) was dispensed to every participant. Both the study CLs and care system were provided to the participants at no cost for the duration of the study.\u003c/p\u003e\u003cp\u003eParticipants were then asked to return to clinic 1 week later for an initial compliance and safety check. Participants were evaluated with SPEED questionnaire, and their high contrast visual acuity while wearing the study CLs was evaluated. The investigator then used a slit-lamp biomicroscope to assess ocular health as described above. The study CLs were evaluated for centration, movement, and coverage, and CL power adjustments were only made if they improve visual acuity. If a participant needed a CL adjustment, they were required to wait a full month before their 1-month follow up visit. Participants were then asked to report for a visit that was schedule about 1 month after they started wearing the study CL. During the 1-month follow-up visit, participants were asked to complete the SPEED questionnaire, a slit-lamp biomicroscope exam, and a CL evaluation as described above, and they were also asked to complete series of investigator-developed questions to evaluate the CL wearing experience. The questionnaire included both Likert questions as well as a visual analog scale (VAS) question that used a 0-100 scale where 100 represented the best possible comfort, 0 represented worst possible comfort, and 50 represented neutral.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e The participants were then compensated for their time, and they were released from the clinical segment of the study. Participants were later electronically contacted 6 months after the baseline visit, and they were asked the same VAS and Likert questions to determine their long-term CL status. CL retention was defined as participant who were still wearing the CLs at a given timepoint.\u003c/p\u003e\n\u003ch3\u003eSample Size and Statistical Analysis Plan\u003c/h3\u003e\n\u003cp\u003eAll data were collected with Research Electronic Data Capture (REDCap; Vanderbilt; Nashville, TN, USA),\u003csup\u003e14, 15\u003c/sup\u003e and the data were analyzed with Stata/BE 18 (StataCorp LLC; TX, USA). This study aimed to understanding if CL dropouts could be comfortably refit into TOTAL30\u0026reg; CLs. The primary outcome of this study was the VAS comfort scores at the 1-month visit. This study did not have a formal sample size calculation given the study\u0026rsquo;s primary outcome was based upon a single arm and was not comparative. Thus, a sample of 60 participants were recruited because it was deemed a reasonable and feasible number of participants who could be recruited over a 6-month period. This number of participants was likewise deemed sufficient to begin to understand the qualitative experience of uncomfortable CL wearers who were being refit into new CLs based upon a past study conducted by the investigators.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eThe data were assumed to be non-normally distributed; therefore, continuous variables were summarized with medians with interquartile ranges (IQR) while categorical results are summarized as percentages. Kruskal\u0026ndash;Wallis tests were used to compare continuous variables across the life of the study. Comparisons were considered significant at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThis study enrolled 61 participants who had a median (IQR) age of 28 (7) years, and 78.7% of the participants were female. The participants identified as Asian (16.4%), Black or African American (9.8%), White (67.2%), More than One Race (4.9%), or Unknown or Not Reported (1.6%) with 1.6% of the participants identifying as Hispanic. Only 1 participant was lost to follow up before the 1-month visit, and only 2 additional participants were lost to follow at 6 months. The participants had a median (IQR) refractive error (sphere/cylinder power) in their right eyes of -1.50 D (2.50 D)/-0.50 D (0.50 D) and \u0026minus;\u0026thinsp;1.75 D (2.75 D)/-0.50 D (0.50 D) in their left eyes. The participants had right and left eye baseline, best-corrected visual acuities of 0.00 (0.10) logMAR and 0.00 (0.10) logMAR, respectively. The participants had finalized CL powers of -1.75 D (2.25 D) and \u0026minus;\u0026thinsp;2.00 D (2.25 D) in their right and left eyes, respectively, at baseline, and only one participant required a CL power change of 0.25 D at the 1-week visit in one eye. The participants had right and left eye baseline CL visual acuities of 0.00 (0.10) logMAR and 0.00 (0.10) logMAR, respectively. Visual acuity with CL did not significantly change over the course of the study (all p\u0026thinsp;\u0026ge;\u0026thinsp;0.64). None of the participants self-reported any adverse event, and no adverse events were detected at study visits via the ocular examinations.\u003c/p\u003e\u003cp\u003eAt 1 month, the participants indicated that they wore their CLs a median of 10.0 (4.0) hours/day over the past week, that they had a median of 8.0 (2.0) hours/day of comfortable wear over the past week, and that they wore their CLs for a median of 5 (2) days over the past week. At 6 months, the participants indicated that they wore their CLs a median of 9.5 (12.0) hours/day over the past week, that they had a median of 6.0 (10.0) hours/day of comfortable wear over the past week, and that they wore their CLs for a median of 4 (6) days over the past week. All the participants that were still in the study at 1 month were wearing the CLs. This resulted in an overall CL retention rate of 98.4% (60/61 participants). However, by 6 months, 18 of the participants who completed the survey were no longer wearing the CLs. This resulted in an overall CL retention rate of 65.6% (40/61 participants).\u003c/p\u003e\u003cp\u003eThe study\u0026rsquo;s primary outcome was CL comfort at the 1-month visit as measured with the same questions in two different formats. The first approach used a 0-100 VAS, which yielded comfortable median comfort scores at both the 1-month (85 [15] units) and 6-month (81 [40] units) timepoints. The second approach used the same question in Likert form with 79.3% of participants indicating that they were either very satisfied or satisfied with their CL comfort over the past week, and only 10.4% of the participants indicated that they were either very unsatisfied or unsatisfied with their CL comfort over the past week at 1 month (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). These data are supported by the participants having a baseline SPEED score of 2.0 (3.0) with SPEED scores of 3.5 (5.5) and 4.0 (5.5) at the 1-week and 1-month visits, respectively; nevertheless, SPEED scores did get significantly worse post-resuming CL wear (p\u0026thinsp;=\u0026thinsp;0.0001). This study also found that 43% of participants had comfortable SPEED scores (scores\u0026thinsp;\u0026le;\u0026thinsp;3) at 1 month.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e The participants additionally reported that they were very satisfied or satisfied with their vision (87.1%) and CL comfort at the end of the day (75.4%) over the past week at 1 month. They likewise indicated that they were very likely or likely to continuing wearing their CLs on a daily basis (72.4%) and 87.0% of the participants indicated that they would recommend the study CLs to a friend at 1 month. The participants indicated that they strongly agreed or agreed that they study CLs allowed them to participate in fitness activities more easily (49.4%), allowed them to use digital devices more easily (49.1%), allowed them to more easily be able to complete general daily activities (63.7%), allowed them to feel more self-confident (57.2%), allowed them to feel less eye fatigue (46.8%), allowed them to feel happier (50.7%), and allowed them to feel less eyestrain (52.0%) at 1 month (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Though the 6-month responses generally include slightly fewer top-2-box ratings and a higher proportion of neutral responses, they follow a similar trend to the 1-month data, with significantly more positive response than negative ones (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eLikert Questionnaire Results\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eQuestions\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1-Month Visit (n\u0026thinsp;=\u0026thinsp;60)\u003c/p\u003e\u003cp\u003eFrequency of Responses (percent)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6-Month Virtual Survey (n\u0026thinsp;=\u0026thinsp;58)\u003c/p\u003e\u003cp\u003eFrequency of Responses (percent)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOverall, how satisfied are you with your vision in your current contact lenses over the past week?\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eVery Satisfied: 48.1%\u003c/p\u003e\u003cp\u003eSatisfied: 39.0%\u003c/p\u003e\u003cp\u003eNeither Satisfied nor Dissatisfied: 10.4%\u003c/p\u003e\u003cp\u003eUnsatisfied: 2.6%\u003c/p\u003e\u003cp\u003eVery Unsatisfied: 0.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eVery Satisfied: 37.9%\u003c/p\u003e\u003cp\u003eSatisfied: 27.6%\u003c/p\u003e\u003cp\u003eNeither Satisfied nor Dissatisfied: 29.3%\u003c/p\u003e\u003cp\u003eUnsatisfied: 5.2%\u003c/p\u003e\u003cp\u003eVery Unsatisfied: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOverall, how satisfied are you with the comfort of your current contact lenses at the end of the day over the past week?\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eVery Satisfied: 24.7%\u003c/p\u003e\u003cp\u003eSatisfied: 50.7%\u003c/p\u003e\u003cp\u003eNeither Satisfied nor Dissatisfied: 13.0%\u003c/p\u003e\u003cp\u003eUnsatisfied: 9.1%\u003c/p\u003e\u003cp\u003eVery Unsatisfied: 2.6%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eVery Satisfied: 15.5%\u003c/p\u003e\u003cp\u003eSatisfied: 34.5%\u003c/p\u003e\u003cp\u003eNeither Satisfied nor Dissatisfied: 37.9%\u003c/p\u003e\u003cp\u003eUnsatisfied: 12.1%\u003c/p\u003e\u003cp\u003eVery Unsatisfied: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOverall, how satisfied are you with the comfort of your current contact lenses over the past week?\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eVery Satisfied: 37.7%\u003c/p\u003e\u003cp\u003eSatisfied: 41.6%\u003c/p\u003e\u003cp\u003eNeither Satisfied nor Dissatisfied: 10.4%\u003c/p\u003e\u003cp\u003eUnsatisfied: 9.1%\u003c/p\u003e\u003cp\u003eVery Unsatisfied: 1.3%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eVery Satisfied: 31.6%\u003c/p\u003e\u003cp\u003eSatisfied: 28.1%\u003c/p\u003e\u003cp\u003eNeither Satisfied nor Dissatisfied: 29.8%\u003c/p\u003e\u003cp\u003eUnsatisfied: 10.5%\u003c/p\u003e\u003cp\u003eVery Unsatisfied: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOverall, how likely are you to continue wearing these contact lenses on a daily basis?\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eVery Likely: 31.6%\u003c/p\u003e\u003cp\u003eLikely: 40.8%\u003c/p\u003e\u003cp\u003eNeither Likely nor Unlikely: 11.8%\u003c/p\u003e\u003cp\u003eUnlikely: 11.8%\u003c/p\u003e\u003cp\u003eVery Unlikely: 4.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eVery Likely: 19.0%\u003c/p\u003e\u003cp\u003eLikely: 32.8%\u003c/p\u003e\u003cp\u003eNeither Likely nor Unlikely: 27.6%\u003c/p\u003e\u003cp\u003eUnlikely: 15.5%\u003c/p\u003e\u003cp\u003eVery Unlikely: 5.2%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWould you recommend your current contact lenses to a friend?\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eYes: 87.0%\u003c/p\u003e\u003cp\u003eNo: 13.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eYes: 80.7%\u003c/p\u003e\u003cp\u003eNo: 19.3%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me to participate in fitness activities more easily.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 23.4%\u003c/p\u003e\u003cp\u003eAgree: 26.0%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 42.9%\u003c/p\u003e\u003cp\u003eDisagree: 2.6%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 2.6%\u003c/p\u003e\u003cp\u003eNot Applicable: 2.6%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 22.4%\u003c/p\u003e\u003cp\u003eAgree: 32.8%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 34.5%\u003c/p\u003e\u003cp\u003eDisagree: 6.9%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 1.7%\u003c/p\u003e\u003cp\u003eNot Applicable: 1.7%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me to use digital devices more easily.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 15.6%\u003c/p\u003e\u003cp\u003eAgree: 32.5%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 41.6%\u003c/p\u003e\u003cp\u003eDisagree: 3.9%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 6.5%\u003c/p\u003e\u003cp\u003eNot Applicable: 0.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 10.3%\u003c/p\u003e\u003cp\u003eAgree: 22.4%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 48.3%\u003c/p\u003e\u003cp\u003eDisagree: 13.8%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 5.2%\u003c/p\u003e\u003cp\u003eNot Applicable: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me more easily complete my general daily activities.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 16.9%\u003c/p\u003e\u003cp\u003eAgree: 46.8%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 29.9%\u003c/p\u003e\u003cp\u003eDisagree: 6.5%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 0.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 13.8%\u003c/p\u003e\u003cp\u003eAgree: 32.8%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 41.4%\u003c/p\u003e\u003cp\u003eDisagree: 12.1%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me to feel more self-confident.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 16.9%\u003c/p\u003e\u003cp\u003eAgree: 40.3%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 39.0%\u003c/p\u003e\u003cp\u003eDisagree: 3.9%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 0.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 22.4%\u003c/p\u003e\u003cp\u003eAgree: 19.0%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 53.5%\u003c/p\u003e\u003cp\u003eDisagree: 5.2%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me to feel less eye fatigue.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 11.7%\u003c/p\u003e\u003cp\u003eAgree: 35.1%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 32.5%\u003c/p\u003e\u003cp\u003eDisagree: 16.9%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 3.9%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 12.1%\u003c/p\u003e\u003cp\u003eAgree: 32.8%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 34.5%\u003c/p\u003e\u003cp\u003eDisagree: 19.0%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 1.7%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me to feel happier.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 13.0%\u003c/p\u003e\u003cp\u003eAgree: 37.7%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 39.0%\u003c/p\u003e\u003cp\u003eDisagree: 10.4%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 0.0%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 15.5%\u003c/p\u003e\u003cp\u003eAgree: 24.1%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 50.0%\u003c/p\u003e\u003cp\u003eDisagree: 10.3%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 0.0%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWearing the study contact lenses has allowed me to feel less eyestrain.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eStrongly Agree: 16.9%\u003c/p\u003e\u003cp\u003eAgree: 35.1%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 28.6%\u003c/p\u003e\u003cp\u003eDisagree: 14.3%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 5.2%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eStrongly Agree: 15.5%\u003c/p\u003e\u003cp\u003eAgree: 27.6%\u003c/p\u003e\u003cp\u003eNeither Agree nor Disagree: 41.4%\u003c/p\u003e\u003cp\u003eDisagree: 13.8%\u003c/p\u003e\u003cp\u003eStrongly Disagree: 1.7%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study is significant because it describes the frequency of past CL wearers who can be comfortably refit into a reusable, daily wear, monthly soft CL. These data are important because they could provide credence for fitting struggling soft CL patients or patients who stopped wearing CLs into an alternative CL, which could help curb the frequency of CL dropout and provide patients an opportunity to continue wearing CLs. This study found that participants could be refit in the study CL with only 3 participants being lost to follow up over this 6-month study and with 79.3% and 59.7% of participants indicating that they were satisfied with their CL comfort over the past week at 1 month and 6 months, respectively. This study likewise found an overall CL retention rate of 98.4% at 1 month and an overall CL retention rate of 65.6% at 6 months. While not every participant in this study was able to achieve comfortable CL wear until when they removed the CLs, this study\u0026rsquo;s results are exceptionally promising given that all included participants were former CL wearers. It is anecdotally not uncommon for practitioners to defer to daily disposable CLs when managing patients at high risk of dropout or already dropped out. This study suggests that patients who previously discontinued reusable CL wear can be comfortably refit with another monthly CL made of lehfilcon A.\u003c/p\u003e\u003cp\u003eCL dropout has been a recognized issue for decades,\u003csup\u003e16\u0026ndash;20\u003c/sup\u003e and the frequency of patients electing to stop wearing CLs has unfortunately been stable over this time period even with the advent of optimized CLs materials, daily disposable CLs, and the development of new pharmaceutical agents.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e One of the most promising studies related to curbing CL dropout was conducted by Young et al. who refit 236 CL dropouts who dropped out of CL at least 1 year ago into any alternative CL brand that was suitable to the participant\u0026rsquo;s needs.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e This study includes a combination of CL materials (silicone hydrogel, hydrogel, rigid gas permeable) and CLdesigns (sphere, toric, bifocal). The authors interestingly found that 77% of participants could be successfully refit into CLs at the 1 month visit and 74% of participant were still wearing the CLs after 6 months.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e More recently Lievens et al. refit 60 CL dropouts with the same entry criteria as the current study into a single brand of daily disposable CLs (Dailies TOTAL1\u0026reg;, delefilcon A) and found that 100% of participants were able to successfully wear the study CLs for 1 month and all but 1 participant were still wearing the CLs after 6 months.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e The current study came to a similar result as these past studies with the current study finding that 98.4% of participants were able to wear the study CLs for 1 month, and 65.6% of participants were still wearing the study CLs at 6 months. Nevertheless, the current study found that the monthly CLs wearers in this study were slightly less satisfied with the comfort of the study CLs (75.4 vs. 78.0%) and with the vision in the study CLs (87.1 vs. 93.2%) at 1 month compared to Lievens et al.\u0026rsquo;s work using delefilcon A daily disposable CLs.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e A similar trend was also noticed when comparing the 6 month data. The current study likewise found that SPEED scores got significantly worse over the first month after reinitiating CL wear compared to baseline, yet this worsening was unlikely to be at a clinically significant level given that the median changes were only 1.5 to 2.0 units and because SPEED score remained low at 1-month.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e The likely reason for the difference between the current work and Lievens et al.\u0026rsquo;s work is that the current study evaluated a monthly, reuseable CL while Lievens et al.\u0026rsquo;s work evaluated a daily disposable CL.\u003csup\u003e9\u003c/sup\u003e These results suggest that previous soft CL dropouts should be closely monitored during the first 6 months of wear after being refit, particularly when being refit into a monthly CL; and if monthly CL wearers are unhappy, they may benefit from being switched to a different CL or more specifically a daily disposable CL.\u003c/p\u003e\u003cp\u003eWhile this study had several strengths, which include the standardization of offering the same monthly CL, enrolling a robust number of CL dropouts, and evaluating the participant\u0026rsquo;s CL wearing experience with multiple instruments, this study is not without limitations. Although using a single CL material is a strength in that it provides consistency among participants, it is also a limitation because the study results can only be directly applied to the material and design tested. Therefore, a similar study could be repeated with alternative CL brands and/or designs to make the results more generally applicable. This study likewise only evaluated a single CL replacement schedule, and because of this issue, a future study should be completed and assess how daily disposable and monthly CLs compare with regards to allowing CL dropouts to return to wearing CLs. The last limitation is that this study only evaluated participants who dropped out of CLs because of discomfort or dryness. While these two issues are the most common reasons for ceasing CL wear, the community would benefit from more data to evaluating how refitting patients into CLs who dropped out of CLs for other reasons (e.g., vision, handling).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study found that many of the participants who dropped out of CLs because of dryness or discomfort could successfully resume CL wear for at least 6 months with lehfilcon A monthly CLs. This success is supported by the current study determining that 79.3% of the participants were satisfied with their CL comfort and that 87.0% of participants would recommend the CLs to a friend after 1 month of wear. A similar positive result was found at 6 months with the current study determining that 59.7% of the participants were satisfied with their CL comfort and that 80.7% of participants would recommend the CLs to a friend. These data are important because they demonstrate that past CL wearers can resume CL wear if given the opportunity to try a new CL material. Refitting with a novel CL material may benefit CL dropouts or patients at high risk of dropout, without requiring a change in replacement schedule. During the study period, participants reported a median of 6 to 8 hours of comfortable wearing time per day and were able to wear the CLs for a median of 4 to 5 days per week. Nevertheless, when data with the monthly CL in this study are compared to the similar work that evaluated a daily disposable CL, more participants who have a history of CL dropout were satisfied with the CL performance if refit into a daily disposable CLs compared to monthly CLs.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e While the results of this study are promising, more work is needed to directly determine how CL dropouts would respond to a different brand of CL or CL wear schedule.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eCommercial Relationship Disclosures\u003c/h2\u003e\u003cp\u003eThe authors have received research support from Abbvie Pharmaceuticals (ADP, CL, SK), Alcon Research, LLC (All), Allergan (CL, SK), Bausch\u0026thinsp;+\u0026thinsp;Lomb (ADP, CL, SK), and Topcon (ADP, CL, SK). The authors have served as consultants for CooperVision (SK, KM), Bausch\u0026thinsp;+\u0026thinsp;Lomb (ADP, CL, SK), Essilor (CL), HanAll Biopharma (ADP), Luxottica (CL), Mintra Health (ADP), RVL Pharmaceuticals, Inc (CL), and Transitions (CL). Dr. Pucker was an employee of Lexitas Pharma Services during the conduct of this work, and he is the owner of Eminent Ophthalmic Services, LLC; neither company makes nor markets an ophthalmic product.\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e\u003cp\u003eThis study was supported with an investigator-initiated study grant from Alcon Vision, LLC, Fort Worth, TX, USA.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAuthors 1 and 9 conceptualized the project, wrote the manuscript and performed the analysis.Authors 2,3,4,5 enrolled subjects, collected data and reviewed the manuscript.Authors 6 \u0026amp; 7 created the case report forms and managed the data and reviewed the manuscript.Author 8 collected data and contributed to manuscript writing and editing.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eNichols JJ, Willcox MD, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: executive summary. \u003cem\u003eInvest Ophthalmol Vis Sci\u003c/em\u003e 2013;54:TFOS7-TFOS13.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePucker AD, Tichenor AA. A Review of Contact Lens Dropout. \u003cem\u003eClin Optom (Auckl)\u003c/em\u003e 2020;12:85\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYoung G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. \u003cem\u003eOphthalmic Physiol Opt\u003c/em\u003e 2002;22:516\u0026ndash;527.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWalline JJ, Jones LA, Sinnott L, et al. Randomized trial of the effect of contact lens wear on self-perception in children. \u003cem\u003eOptom Vis Sci\u003c/em\u003e 2009;86:222\u0026ndash;232.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGuthrie S, Ng A, Woods J, Vega J, Orsborn G, Jones L. Exploring the factors which impact overall satisfaction with single vision contact lenses. \u003cem\u003eCont Lens Anterior Eye\u003c/em\u003e 2022;45:101579.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eQueiros A, Villa-Collar C, Gutierrez AR, Jorge J, Gonzalez-Meijome JM. Quality of life of myopic subjects with different methods of visual correction using the NEI RQL-42 questionnaire. \u003cem\u003eEye Cont Lens\u003c/em\u003e 2012;38:116\u0026ndash;121.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMaldonado-Codina C, Navascues-Cornago M, Plowright AJ, et al. Using face masks with spectacles versus contact lenses. \u003cem\u003eCont Lens Anterior Eye\u003c/em\u003e 2022;45:101516.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. \u003cem\u003eOphthalmology\u003c/em\u003e 2003;110:2292\u0026ndash;2301.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLievens C, Pucker AD, Rayborn E, et al. Refitting contact lens dropouts into a modern daily disposable contact lens. \u003cem\u003eOphthalmic Physiol Opt\u003c/em\u003e 2024;44:686\u0026ndash;692.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCall T, Pucker AD, McGwin G, Jr., Franklin QX, Logan A. Real-Time Ocular Comfort Reporting in Monthly Replacement Contact Lens Wearers. \u003cem\u003eClin Optom (Auckl)\u003c/em\u003e 2023;15:97\u0026ndash;103.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIshihara K, Shi X, Fukazawa K, Yamaoka T, Yao G, Wu JY. Biomimetic-Engineered Silicone Hydrogel Contact Lens Materials. \u003cem\u003eACS Appl Bio Mater\u003c/em\u003e 2023;6:3600\u0026ndash;3616.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAsiedu K, Kyei S, Mensah SN, Ocansey S, Abu LS, Kyere EA. Ocular Surface Disease Index (OSDI) Versus the Standard Patient Evaluation of Eye Dryness (SPEED): A Study of a Nonclinical Sample. \u003cem\u003eCornea\u003c/em\u003e 2016;35:175\u0026ndash;180.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePucker AD, Dougherty BE, Jones-Jordan LA, Kwan JT, Kunnen CME, Srinivasan S. Psychometric Analysis of the SPEED Questionnaire and CLDEQ-8. \u003cem\u003eInvest Ophthalmol Vis Sci\u003c/em\u003e 2018;59:3307\u0026ndash;3313.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHarris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international community of software platform partners. \u003cem\u003eJ Biomed Inform\u003c/em\u003e 2019;95:103208.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. \u003cem\u003eJ Biomed Inform\u003c/em\u003e 2009;42:377\u0026ndash;381.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWeed K, Fonn D, R. P. Discontinuation of contact lens wear. Optom Vis Sci. 1993;70(Suppl):140.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eS. B. Profile of contact lens failures in Saudi Arabia. \u003cem\u003eClin Exp Optom\u003c/em\u003e 1996;79:255\u0026ndash;259.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePritchard N, Fonn D, Brazeau D. Discontinuation of contact lens wear: a survey. \u003cem\u003eInt Contact Lens Clin\u003c/em\u003e 1999;26:157\u0026ndash;162.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRichdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with contact lens dissatisfaction and discontinuation. \u003cem\u003eCornea\u003c/em\u003e 2007;26:168\u0026ndash;174.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDumbleton K, Woods CA, Jones LW, Fonn D. The impact of contemporary contact lenses on contact lens discontinuation. \u003cem\u003eEye Cont Lens\u003c/em\u003e 2013;39:93\u0026ndash;99.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePucker AD, Derthick N, Scott L. Running the enrollment numbers on ophthalmic clinical trials in the United States. \u003cem\u003eOptom Vis Sci\u003c/em\u003e 2024;101:523\u0026ndash;529.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"ophthalmic-and-physiological-optics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Ophthalmic and Physiological Optics](https://link.springer.com/journal/44402)","snPcode":"44402","submissionUrl":"https://submission.springernature.com/new-submission/44402/3?","title":"Ophthalmic and Physiological Optics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Open","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Contact Lens, Monthly, Discomfort, Dropout, TOTAL30, lehfilcon A","lastPublishedDoi":"10.21203/rs.3.rs-7879757/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7879757/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e\u003cp\u003eTo refit contact lens (CL) dropouts who dropped out of CLs because of dryness or discomfort into TOTAL30\u0026reg; (lehfilcon A) monthly, spherical CLs to determine the frequency that they can be comfortably refit into CLs.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA 6-month, 4 visit, multi-center study was conducted. Adult, 18- to 40-year-old, past CL wearers who dropped out of CLs within the past 2 years because of discomfort or dryness were enrolled. Participants were required to have no dry eye symptoms (SPEED scores\u0026thinsp;\u0026le;\u0026thinsp;3). All participants were then fit in TOTAL30\u0026reg; CLs. The participants were evaluated with the SPEED, a comfort visual analog scale (VAS; 0-100 scale), and a Likert questionnaire.\u003c/p\u003e\u003ch2\u003eResult\u003c/h2\u003e\u003cp\u003eThis study enrolled 61 participants who had a median (interquartile) age of 28 (7) years (78.7% female). This study had a CL retention rate of 98.4% at 1 month and 65.6% at 6 months. The VAS yielded a median comfort score of 81 (40) at 6 months. The Likert questionnaire found that 80.7% of participants would recommend the CLs to a friend at 6 months. SPEED scores increased statistically post-resuming CL wear (p\u0026thinsp;=\u0026thinsp;0.0001) at 1 month, yet this symptoms change was unlikely clinically meaningful.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eThis study found that previous CL wearers who had dropped out of CLs could be comfortably refit with lehfilcon A monthly silicone hydrogel CLs, with the majority of them continuing to wear the CLs at 6 months. The results suggest that the monthly soft CLs with water gradient technology can be a viable option for many CL dropout suffers.\u003c/p\u003e","manuscriptTitle":"Perform of a Monthly, Reusable, Soft Contact Lens in Participants Who Previously Dropped Out of Contact Lenses","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-31 07:07:36","doi":"10.21203/rs.3.rs-7879757/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-01-29T13:37:55+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-28T23:02:33+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"317679023732449631137469076090145224680","date":"2025-12-10T08:57:20+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-12-01T23:42:07+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"24357146522419677606258843145791454141","date":"2025-11-17T16:46:24+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-21T13:21:05+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-21T13:17:04+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-21T00:37:02+00:00","index":"","fulltext":""},{"type":"submitted","content":"Ophthalmic and Physiological Optics","date":"2025-10-16T16:24:31+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"ophthalmic-and-physiological-optics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Ophthalmic and Physiological Optics](https://link.springer.com/journal/44402)","snPcode":"44402","submissionUrl":"https://submission.springernature.com/new-submission/44402/3?","title":"Ophthalmic and Physiological Optics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Open","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7a428b77-9985-4081-bdb8-c8369813be41","owner":[],"postedDate":"October 31st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-03-18T12:55:52+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-31 07:07:36","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7879757","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7879757","identity":"rs-7879757","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}