Efficacy and Tolerability of Travoprost 0.004 % /Timolol 0.5 % Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy

Objective. to evaluate the efficacy and tolerability of travoprost 0.004%/timolol 0.5% fixed-dose combination (ttfc) in patients with open-angle glaucoma (oag) or ocular hypertension (oht) inadequately controlled on beta-blocker monotherapy. methods. in this phase iv,open-label study,156 patients on beta-blocker monotherapy with mean intraocular pressure (iop) between 18 and 32 mmhg were randomized (no washout period) to receive ttfc for 8 weeks (ttfc group) or to continue beta-blocker monotherapy for 4 weeks followed by ttfc for the remaining 4 weeks (beta-blocker group). results. the mean iop (�standard deviation) at baseline in the ttfc and beta-blocker groups was 22.5�2.5 mmhg and 22.2�2.3 mmhg,respectively,and at weeks 4 and 8,was 16.7�3.1 mmhg and 16.1�3.1 mmhg,respectively,in ttfc group and 21.1�3.1 mmhg and 16.1�2.8 mmhg,respectively,in the beta-blocker group. there was a significant least squares mean difference between ttfc and beta-blocker in 8 a.m. iop at week 4 (-4.6 mmhg; one-sided 95% confidence interval [-inf,-3.9]; p<0.0001 [primary endpoint]); the upper bound of the 95% confidence interval was within the prespecified limit (<0). both treatments were well tolerated. conclusion. superior iop control was achieved with ttfc in patients with oag or oht previously uncontrolled with beta-blockers. no new safety findings were identified. this trial is registered with clinicaltrials.gov nct02003391. � 2017 simon fabian lerner et al.