Comparisons for Evaluation of Efficacy and Safety of Cyclosporin A 0.05% Ophthalmic Emulsion Treatment Groups

ABSTRACT

PURPOSE: To evaluate and compare the efficacy and safety of cyclosporine 0.05% (Cyporin N eye drops 0.05%) to an active comparator (Restasis®) in moderate to severe dry eye patients. METHODS: This is a multicenter, randomized, double-blind, parallel, active control, non-inferiority, phase III study. Patients had a 2-week run-in period (during the run-in period, patients used artificial tears, if applicable), and afterward 158 patients were randomly assigned treatment for 12 weeks with cyclosporine 0.05% (with artificial tears, if applicable), in which the efficacy and safety were evaluated every four weeks. RESULTS: Corneal staining tests showed that in the per protocol set group, the study group was not inferior to the control group; the results for the full analysis set analytic group were the same. The number of adverse events reported from the 158 patients was not significantly different between groups (p = 0.1107). Additionally, other evaluations, including tolerability evaluations, clinical pathology examinations, and vital signs, show that there is no difference in terms of safety between the groups. CONCLUSIONS: Cyclosporine A 0.05% (Cyporin N eye drops 0.05%) is considered to have the same efficacy and safety compared to the active comparator.