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PURPOSE: A long-term comparison of the ocular hypotensive efficacy and safety of unoprostone isopropyl 0.15% twice daily with that of timolol maleate 0.5% twice daily and betaxolol HCl 0.5% twice daily.DESIGN: This was a randomized, multicenter, double-masked, active-controlled 24-month clinical trial involving 27 centers in Europe and Israel. METHODS: The study population was composed of patients with primary open-angle glaucoma (including pseudoexfoliation) or ocular hypertension. After washout of antiglaucoma medications, intraocular pressure (IOP) was measured at 0, +2, +8, and +12 hours. Patients were randomized in a 2:1:1 ratio to unoprostone, timolol, or betaxolol. Patients returned for examinations at two and six weeks and three and six months. RESULTS: Five hundred and fifty-six patients were randomized. Each drug produced a clinically and statistically (p Dr. J.P. Nordmann, Hopital National d'Ophtalmologie des Quinze Vingts, Paris, France 11.4 Prostaglandins (Part of: 11 Medical treatment)Classification: