Efficacy and safety of topical cyclosporine 0.1% in moderate-to-severe dry eye disease refractory to topical cyclosporine 0.05% regimen

PURPOSE: To evaluate the efficacy and safety of 0.1% cyclosporine A cationic emulsion (CsA CE) following prior treatment with 0.05% cyclosporine A anionic emulsion (CsA AE) in moderate to severe dry eye disease (DED). MATERIALS AND METHODS: We retrospectively identified patients with moderate-to-severe DED who had shown an inadequate response to twice-daily use of topical 0.05% CsA AE but showed a significant improvement after switching to 0.1% CsA CE daily. Dry eye parameters before and after CsA CE were evaluated by tear break-up time (TBUT), corneal fluorescein staining (CFS), cornea sensitivity, Schirmer's test without anesthetics, and Ocular Surface Disease Index questionnaire. RESULTS: Twenty-three patients, including ten patients with Sjogren syndrome and five patients with rheumatoid arthritis, were reviewed. After a 2-month course of treatment with topical 0.1% CsA CE, significant improvements were noted for CFS (P < 0.001), corneal sensitivity (P = 0.008), and TBUT (P = 0.01). Efficacy was similar in the autoimmune versus nonautoimmune group. 39.1% of patients reported treatment-related adverse events, while the majority was transient instillation pain. Visual acuity and intraocular pressure had no significant changes during the study. CONCLUSION: In patients with moderate to severe DED refractory to 0.05% cyclosporine, shifting to 0.1% cyclosporine showed improvement in objective signs but with lower treatment tolerability in the short term.