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PURPOSE: To evaluate the intraocular pressure-lowering efficacy and safety of travoprost 0.0015% and 0.004%, dosed daily in the evening compared with vehicle, in patients with open-angle glaucoma or ocular hypertension, whose intraocular pressure (IOP) was not adequately controlled on timolol 0.5% twice daily (twice daily). METHODS: Subjects who qualified at screening began a run-in period dosing timolol twice daily for three weeks. If the subjects had an IOP of 24-36 mmHg at 8 a.m. and 21-36 mmHg at 10 a.m. and 4 p.m. in at least one eye on timolol, they were randomized to one of two concentrations of travoprost (0.0015% or 0.004%) or vehicle solution every day and were followed for six months. Four hundred and twenty-six subjects were randomized. The mean IOP at 8 a.m., 10 a.m., and 4 p.m. in the patient's eye with the higher IOP was used for the analysis. RESULTS: Mean baseline values (25 mmHg) for subjects at eligibility (while maintained on timolol) were not significantly different (p < 0.0001) among the treatment groups. The IOP was lowered an additional -5.7 to -7.2 mmHg and -5.1 to -6.7 mmHg in the travoprost 0.004% and 0.0015% concentrations, respectively. These changes were significantly (p
Dr S. Orengo-Nania, Baylor College of Medicine, Houston, TX, USA
11.4 Prostaglandins (Part of: 11 Medical treatment)