A 6-week, double-masked, parallel-group study of the efficacy and safety of travoprost 0.004% compared with latanoprost 0:005%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension.

The objective of this study was to directly compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004% eyedrops with the fixed combination of latanoprost 0.005%/timolol 0.5% eyedrops in patients with primary open-angle glaucoma or ocular hypertension. This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. Adult subjects with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension were eligible to participate if their IOP was inadequately controlled with > or =4 weeks of beta-blocker monotherapy, as indicated by IOP of 22 to 36 mm Hg at 9 AM at screening. Patients were randomly assigned in a 1:1 ratio to receive placebo + travoprost or latanoprost/timolol + placebo. Patients in the travoprost group administered travoprost at 9 PM and placebo at 9 AM; patients in the latanoprost/timolol group administered latanoprost/timolol at 9 AM and placebo at 9 PM. IOP measurements were performed using Goldmann applanation tonometry at 9 AM and 5 PM at the week-2 and week-6 visits. Both volunteered and elicited reports of adverse events were collected; all patients who were randomized and received > or =1 dose of study drug were included in the safety analysis. One hundred ten patients were randomized, of whom 106 patients were evaluable (travoprost, n = 50; latanoprost/timolol, n = 56). There were no statistically significant differences at baseline between the treatment groups, based on age group, sex, race, iris color, or diagnosis. Mean IOP values were not statistically different between groups at baseline or during treatment. In the pooled results for 9 Am assessment at weeks 2 and 6, mean (SEM) IOP reductions for travoprost and latanoprost/timolol were 7.0 (0.5) and 6.4 (0.5) mm Hg, respectively (P = NS). Adverse events related to therapy were mild in nature, and there were no statistically significant differences between the 2 treatment groups. The most frequently experienced adverse events in the travoprost group were ocular hyperemia (9.3%), foreign body sensation (5.6%), abnormal vision (1.9%), allergic reaction (1.9%), conjunctivitis (1.9%), dacryocystitis (1.9%), eye discharge (1.9%), eye pruritus (1.9%), lid edema (1.9%), lid erythema (1.9%), and tearing (1.9%). In the latanoprost/timolol group, the most frequently experienced adverse events were cataract (1.8%), dry eyes (1.8%), eye pruritus (1.8%), foreign body sensation (1.8%), and ocular hyperemia (1.8%). Mean IOP changes from baseline for travoprost 0.004% and latanoprost 0.005%/timolol 0.5% fixed combination were not significantly different at follow-up in these patients. Both medications were well tolerated.