Effects of a Novel Ophthalmic Solution Containing Glicopro® Complex on Signs and Symptoms of Patients with Dry Eye Disease

Purpose: To evaluate the changes in signs and symptoms of patients with dry eye disease (DED) treated with a novel tear substitute based on the GlicoPro® complex along with its effects on the tear content. Methods: In this prospective study, patients with DED not successfully responding to conventional tear substitutes were treated with a novel eye drop based on the GlicoPro® complex (posology of 4 times daily). Patients were examined before starting study treatment (T0) and after 30 days (T1) and 60 days (T2) by means of Keratograph 5M (Oculus, Wetzlar, Germany) for the evaluation of: i) tear meniscus height (TMH); ii) non-invasive breakup time (NIBUT) a) first, b) average and c) class; iii) bulbar redness; iv) infrared meibography for the calculation of meibomian glands loss (MGL). Symptom Assessment in Dry Eye (SANDE) questionnaire was administered at each time point to assess ocular discomfort symptoms. In the subgroup of patients whose TMH at T0 was ≥ 0.25 mm, the analysis of tear content was conducted to measure Proenkephalin and Met/Leu-enkephalinproenkephalin (reported as processed active peptides). Results: Overall, 60 patients (23 males, 37 females; mean age 67.00 ± 8.00 years) were enrolled. At T2, a significant improvement of NIKBUT first (from 4.01 [2.87–5.88] seconds [s] to 7.90 [5.28–11.76] s; p < 0.0001), NIKBUT average (from 9.63 ± 5.03 s to 13.85 ± 4.88 s; p < 0.0001), NIBUT class (from 1.00 [0.00–2.00] to 1.00 [0.00–1.00]; p < 0.05) and TMH (from 0.28 [0.21–0.39] millimetres [mm] to 0.32 [0.24–0.40] mm; p < 0.01); in parallel, SANDE score significantly decreased at T2 (from 60.60 [52.21–68.90] to 35.60 [27.53–44.33]; p < 0.0001). In the subgroup of patients (n = 9) undergone tear analysis, a statistically significant increase in the mean value of enkephalins and proenkefalin was observed at T2 and T1 respectively (from 1 ± 0.56 to 1.46 ± 1.24; p < 0.01 and 1 ± 0.63 to 1.43 ± 0.73; p < 0.01). No patients reported adverse events related to study treatment. Conclusions: The novel tear substitute based on GlicoPro® resulted in significant improvement of ocular discomfort symptoms as well as tear volume and stability in patients with DED not responding to conventional tear substitutes. The increase in active peptides processed in tears may represent the pathophysiological substrate underlying this finding.