Three Month Comparison of the Safety and Efficacy of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution to TRAVATAN® and Timolol 0.5%.

Abstract

Abstract: : Purpose: To compare the IOP–lowering efficacy of Travoprost 0.004%/Timolol 0.5% (Trav/Tim) to either TRAVATAN^® (Travoprost 0.004%, Trav) or Timolol 0.5% (Tim) alone. Methods: This was a double–masked, randomized, active–controlled, parallel–group trial. After appropriate washout, patients with open–angle glaucoma or ocular hypertension were randomly allocated to receive Trav/Tim (AM) plus Tim Vehicle (PM); Tim Vehicle (AM) plus Trav (PM); or Tim (AM & PM). Intraocular pressure (IOP) was measured at 8 AM, 10 AM, and 4 PM at baseline, Week 2, Week 6, and Month 3. Results: Trav/Tim produced statistically significant and clinically relevant IOP reductions from baseline, with mean reductions ranging from 9–12 mmHg (32–38%). Of the 263 patients enrolled in the study, 258 were eligible for intent–to–treat analysis at Month 3. Across the day, mean baseline IOP ranged from 27.2–30.2 mmHg (Trav/Tim), 26.6–29.6 mmHg (Trav), and 26.8–29.2 mmHg (Tim). Trav/Tim produced statistically significantly lower mean IOP than Tim alone at all visits and times with mean IOP change differences in favor of Trav/Tim ranging from 1.9–3.3 mmHg. Trav/Tim produced greater IOP lowering than Trav at all times of day and most importantly at the crucial 8 AM time point when the mean IOP change differences favoring Trav/Tim ranged from 2.0–2.4 mmHg. Statistical superiority (p < 0.05) was achieved at all 8 AM time points, at Week 2, 10 AM and 4 PM, at Week 6, 10 AM, and at Month 3, 10 AM. Trav/Tim produced clinically relevant IOP control with up to 55% of patients achieving IOP levels <18 mmHg. No safety concerns were noted for hyperemia, pulse, or systemic blood pressure. Conclusions: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution reduced mean IOP more than either TRAVATAN^® or Timolol 0.5% alone. The IOP reductions, ranging from approximately 9 to 12 mmHg, were statistically significant and clinically relevant. Travoprost 0.004%/Timolol 0.5% ophthalmic solution was safe and well tolerated.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • pharmacology • intraocular pressure