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PURPOSE: To evaluate the safety and efficacy of adding unoprostone isopropyl 0.12% versus placebo both given twice daily to latanoprost 0.005% given every evening. METHODS: The authors treated 41 patients with primary open-angle glaucoma or ocular hypertension with latanoprost 0.005% for one month and then randomized each to either placebo or unoprostone isopropyl 0.12% for eight weeks. Diurnal intraocular pressures were measured at 08:00, 10:00, 12:00, 18:00, and 20:00 hours, both at baseline (time of randomization) and after eight weeks of treatment. RESULTS: Twenty patients were treated in the placebo group and 21 in the unoprostone isopropyl group. After eight weeks of treatment in the placebo group, the trough intraocular pressure at 08:00 and the diurnal pressure were 20.4 ± 3.2 and 19.1 ± 2.2 mmHg, respectively. In the unoprostone isopropyl group the pressures were 19.4 ± 3.3 and 18.0 ± 1.7 mmHg (p = 0.22 and 0.042), respectively. However, eyes with a baseline pressure of 22 mmHg or greater on latanoprost had an average 3.3 mmHg greater reduction at trough (p < 0.01) and a 2.1 mmHg greater decrease in diurnal pressure (p = 0.030) after adding unoprostone isopropyl (n = 14 eyes) compared with placebo (n = 16 eyes; p < 0.001). In addition, the range of the pressures throughout the diurnal curve was reduced from 2.7 mmHg on latanoprost alone to 1.4 mmHg after adding unoprostone isopropyl. Adverse events were similar between groups, and no patients were discontinued because of safety reasons. CONCLUSIONS: This study suggests that unoprostone isopropyl can safely improve the diurnal curve characteristics in patients who continue to have an elevated pressure on latanoprost 0.005% alone.
Dr W.C. Stewart, Pharmaceutical Res. Corporation, 1639 Tatum Street, Charleston, SC 29412-2464, USA
11.4 Prostaglandins (Part of: 11 Medical treatment)