A 5-year, Randomized, Open-Label Safety Study of Latanoprost and Usual Care in Patients with Open-Angle Glaucoma or Ocular Hypertension

PURPOSE: To investigate the incidence of latanoprost-related adverse events of the cornea, iris, and retina and the occurrence of hyperpigmentation. METHODS: An open-label safety surveillance study was conducted in 14 countries. Patients on intraocular pressure (IOP)-reducing therapy other than latanoprost were eligible if they required a change in therapy. Patients were randomly assigned (2:1) to latanoprost administered once daily or to usual care (any other commercially available medication). Patients were examined at baseline and every 6 months for 5 years. RESULTS: In all, 5854 patients were included (latanoprost, 3936; usual care, 1918). Of those initially randomized to latanoprost, 2707 (68.8%) completed the study, and 4638 (79.2%) patients received at least one dose of latanoprost. Five-year risks were < or = 3.17% for new occurrences of corneal erosions, iritis/uveitis, or macular edema in both randomization groups. Serious adverse drug reactions were reported in 17/3936 (0.43%) latanoprost and 9/1918 (0.47%) usual care patients. In all, 87.6% of patients ever treated with latanoprost had no increased iris pigmentation; no serious adverse drug reactions were reported in patients with increased iris pigmentation. CONCLUSIONS: This 5-year study suggests that latanoprost as prescribed in 14 countries is a safe long-term treatment for patients with glaucoma and ocular hypertension.