Exploration of Efficacy and Mechanism of 0.05% Cyclosporine Eye Drops (II) Monotherapy in Allergic Conjunctivitis-associated Dry Eye

Purpose: To explore the efficacy and relevant mechanism of 0.05% cyclosporine A (CsA) eye drops (II) monotherapy in patients with allergic conjunctivitis-associated dry eye (ACDE). Methods: Prospective, randomized, controlled study. Fifty-three patients with mild-to-moderate ACDE were randomly assigned to two groups. The CsA group received 0.05% CsA eye drops (II) monotherapy four times daily. The control group received 0.1% olopatadine twice daily combined with 0.1% preservative-free artificial tears four times daily. Clinical symptoms and signs, tear total IgE, and lymphotoxin-α (LT-α) concentrations were assessed at pre- and post-treatment days 7, 30, and 60. And we further measured six tear inflammatory cytokines levels using a microsphere-based immunoassay. Results: The CsA group showed significant improvement in symptoms (Ocular Surface Disease Index and itching scores) and signs (conjunctival hyperemia, conjunctival edema, conjunctival papillae, tear break-up time (TBUT), corneal fluorescent staining, and goblet cell density) at each follow-up period compared to pre-treatment (all P <0.050). And its improvement in itching scores ( P 7th <0.001, P 30th =0.039, and P 60th =0.031) and TBUT ( P 7th =0.009, P 30th =0.003, and P 60th =0.005) was more significant than the control group at all follow-up periods. The tear total IgE, interleukin (IL)-5, IL-6, periostin, eotaxin-3, and MMP-9 levels significantly decreased in the CsA group at day 60 after treatment (all P <0.050). And the changed values in tear total IgE were positively correlated with the change in itching scores. Conclusions: 0.05% CsA eye drops (II) monotherapy can rapidly improve the symptoms and signs, especially in ocular itching and TBUT, in patients with ACDE. And its efficacy is superior to 0.1% olopatadine combined with artificial tears. Moreover, CsA downregulates the expression levels of tear inflammatory cytokines, including tear total IgE, IL-5, IL-6, periostin, eotaxin-3, and MMP-9. Among that, the reduction in tear total IgE levels may reflect the improvement of ocular itching.