The Efficacies and Safeties of a 0.05% Cyclosporine Nanoemulsion and a 0.1% Cyclosporine Cationic Emulsion

Abstract

Purpose: We evaluated the efficacy and safety of a 0.05% cyclosporine ophthalmic nanoemulsion and a 0.1% cyclosporine ophthalmic cationic emulsion in patients with moderate-to-severe dry-eye syndrome.Methods: This was a multi-center, double-blinded, comparative, prospective, randomized clinical trial. Three ophthalmological institutions enrolled a total of 105 patients with moderate-to-severe dry eye who were randomly assigned to a 0.05% cyclosporine nanoemulsion group (the test group) and a 0.1% cyclosporine cationic emulsion group (the control group). The corneal staining scores were obtained, and the tear film breakup time (TBUT) and Schirmer test performed, at the initial visit and after 1 and 3 months of eyedrop use. The safety results were compared by recording discomfort and compliance during drug instillation.Results: The corneal staining scores and the TBUT and Schirmer test results showed that both groups showed significant improvements. The corneal staining scores significantly (and similarly) decreased in both groups. In the test group, the TBUT showed significant prolongation after 1 month of treatment and the Schirmer test score increased significantly after 3 months. Both groups reported less ocular discomfort and better compliance with drug use at 3 months than 1 month; the control group demonstrated a significant decrease in ocular discomfort at 3 months.Conclusions: Both drugs improved the dry eye symptom index and relieved eye discomfort. No patient complained of serious discomfort or side-effects. The drugs were equivalent in terms of efficacy and safety.