Cyclosporine ophthalmic emulsion's efficacy and safety in moderate to severe dry eye patients: A randomized controlled trial

Abstract

Background: Moderate to severe dry eye disease (DED) is associated with significant pain, limitations in performing daily activities, reduced life quality, and often depression. This work aimed to evaluate the effectiveness and safety of cyclosporine A (CsA) ophthalmic emulsion in moderate to severe dry eye patients.Methods: This controlled, randomized, double-blinded study was conducted on forty patients at least 18 years of age, both sexes, diagnosed with keratoconjunctivitis sicca, whether or not it was accompanied by Sjogren's syndrome. The patients were allocated to two equal groups: Group A: patients were treated twice daily with 0.1% cyclosporine A, and Group B: patients were treated twice daily with the vehicle in both eyes for 12 weeks.Results: Oxford grading scale was significantly higher at 4w, 8w, 12w and 4w posttreatment in group A in comparison to group B (P