Topical Cyclosporine 0.05% for the Prevention of Dry Eye Disease Progression

Abstract

PURPOSE: To assess the prognosis of dry eye in patients treated with cyclosporine 0.05% or artificial tears by using the International Task Force (ITF) guidelines. METHODS: This was a single-center, investigator-masked, prospective, randomized, longitudinal trial. Dry eye patients received twice-daily treatment with either cyclosporine 0.05% (Restasis; Allergan, Inc., Irvine, CA; n = 36) or artificial tears (Refresh Endura; Allergan, Inc., Irvine, CA; n = 22) for 12 months. Disease severity was determined at baseline and month 12 according to the consensus guidelines developed by the ITF. Dry eye signs and symptoms were evaluated at baseline and months 4, 8, and 12. RESULTS: Baseline sign and symptom scores and the proportion of patients with the disease severity level 2 or 3 were comparable in both groups (P > 0.05). At month 12, 34 of 36 cyclosporine patients (94%) and 15 of 22 artificial tear patients (68%) experienced improvements or no change in their disease severity (P = 0.007) while 2 of 36 cyclosporine patients (6%) and 7 of 22 artificial tears patients (32%) had disease progression (P < 0.01). Cyclosporine 0.05% improved Schirmer test scores, tear breakup time, and Ocular Surface Disease Index scores throughout the study, with significant (P < 0.01) differences compared with artificial tears being observed at months 8 and 12. CONCLUSIONS: Treatment with cyclosporine 0.05% may slow or prevent disease progression in patients with dry eye at severity levels 2 or 3.