A Comparison of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution to the Concomitant Administration of Travoprost 0.004% and Timolol 0.5% Ophthalmic Solutions and to Timolol 0.5% Ophthalmic Solution Alone

Abstract

Abstract: : Purpose: To compare the IOP–lowering efficacy of Travoprost 0.004%/Timolol 0.5% ophthalmic solution (Trav/Tim) to the concomitant administration of Travoprost 0.004% and Timolol 0.5% (Trav+Tim) and to Timolol 0.5% (Tim) b.i.d. Methods: This was a double–masked, randomized, parallel group, multi–site study in patients (pts) with open–angle glaucoma or ocular hypertension. Qualifying pts, whose entry IOP was 22–36 mmHg at 8 am on 2 separate eligibility visits, were randomized to receive Trav/Tim in the am (n=155) or Tim in the am plus Trav in the pm (n=151) or Tim am + pm (n=81). Mean IOP was measured at 8 am, 10 am, & 4 pm on follow–up treatment visits at Week 2, Week 6, & Month 3. Statistical analyses were based on ANOVA using SAS for Windows 8.2. Results: Mean baseline IOP in the per–protocol data set ranged across the day 23.1–25.6 mmHg (Trav/Tim), 22.9–25.0 mmHg (Trav+Tim), & 22.9–25.4 mmHg (Tim). Mean IOP reductions from baseline produced by Trav/Tim ranged 6.8–8.6 mmHg (p≤0.0001), by Trav+Tim ranged 7.3–8.4 mmHg (p≤0.0001), & by Tim ranged 4.6–7.0 mmHg (p≤0.0001). Trav/Tim reduced diurnal mean IOP in a fashion similar to Trav+Tim, with differences in mean IOP change ranging 0.1–1.0 mmHg between the two groups (0.0126≤p≤0.8955). 2 of 9 time points showed significantly greater IOP reduction by concomitant Trav+Tim (p≤0.0185). Trav/Tim achieved greater IOP reduction than Tim alone at all time points (p≤0.0192). 68% of patients using Trav/Tim achieved IOP <18 mmHg at any time point compared to 22% of patients who achieved IOP <18 mmHg throughout the entire 3–month period. Conclusion: Travoprost 0.004%/Timolol 0.5% ophthalmic solution was effective in lowering IOP in patients with open angle glaucoma or ocular hypertension. The combination eyedrop offered the convenience of once daily dosing while maintaining IOP–lowering efficacy similar to concomitant administration of the individual components and superior to Timolol 0.5% b.i.d.

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