Comparison of Efficacy and Sensation of Instillation between 0.05% Cyclosporine Nanoemulsion and Microemulsion Type

ABSTRACT

PURPOSE: To evaluate and compare the efficacy and sensation of instillation between 0.05% cyclosporine nanoemulsion group and microemulsion group. METHODS: This is a double-blind, prospective randomized clinical trial. Patients had 2 weeks of wash-out period before the study. They were randomly assigned to either nanoemulsion group or microemulsion group and treated with each group's cyclosporine eye drop. Artificial eye drop and topical steroid were used together according to severity of dryness of cornea. We checked every patient's Break-up time (BUT), Schirmer test, Staining Score and Ocular surface disease index (OSDI) on baseline, 1 month and 3 months after. Patients also self-checked frequency of use of artificial eye drop and topical steroid. Sensation of instillation was also checked. RESULTS: Both nanoemulsion eye-drop and microemulsion eye-drop improved BUT, Schirmer test, Staining Score and OSDI throughout 12 weeks. The nanoemulsion type reduced OSDI significantly compared to the microemulsion type. The mean frequency of use of artificial tear and topical steroid was similar in both groups. Foreign body sense score was higher in microemulsion group. CONCLUSIONS: 0.05% cyclosporine nanoemulsion type has simillar efficacy and subjectively less foreign body sensation.