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.

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.

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.

Cyclosporine A 0.05% (Cyporin N eye drops 0.05%) is considered to have the same efficacy and safety compared to the active comparator.