Abstract
To evaluate the efficacy and safety of fixed combination latanoprost/timolol versus latanoprost or timolol monotherapy. This 12-week, randomized, double-masked study was designed to overcome potential shortcomings of previous trials. We enrolled 788 subjects with open-angle glaucoma or ocular hypertension treated with a beta-blocker for > or = 4 weeks before screening. After washout, 500 subjects with a baseline mean intraocular pressure (IOP) > or = 26 and < 37 mmHg were randomized to fixed combination latanoprost-timolol in the evening (n = 170), latanoprost monotherapy in the evening (n = 165), or timolol monotherapy in the morning (n = 165). At weeks 2, 6, and 12, each subject's IOP level was measured in triplicate at 8 AM (predose), 10 AM, and 4 PM in each eye. Adverse events were monitored throughout. The statistical superiority of the fixed combination for the 18 pairwise comparisons with the 2 monotherapies was evaluated (analysis of variance). RESULTS. The statistical superiority of the fixed combination was demonstrated at 7/9 time points versus latanoprost and 9/9 time points versus timolol. Mean diurnal IOP levels were similar at baseline but significantly lower with the fixed combination than with either monotherap...Continue Reading
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