A Comparison of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution and the Concomitant Administration of TRAVATAN® and Timolol 0.5%

Abstract

Abstract: : Purpose: To compare the IOP–lowering efficacy of the fixed combination of Travoprost 0.004%/Timolol 0.5% (Trav/Tim) to the concomitant administration of TRAVATAN^® and Timolol 0.5% (Trav + Tim). Methods: This was a double–masked, randomized, parallel group multi–site study in patients with open–angle glaucoma or ocular hypertension. Following a wash–out of 5 days to 4 weeks from their previous ocular hypotensive medications, patients’ baseline IOPs were measured at 8 am, 10 am, and 4 PM. Entry IOP was 22–36 mmHg at 8 am on two separate eligibility visits. Follow–up treatment visits were conducted at Week 2, Week 6, and Month 3. Patients were randomized to either Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (Trav/Tim) am plus Timolol vehicle PM (n=151) or Timolol am plus TRAVATAN^® PM (Trav + Tim)(n=142). Statistical analyses were based on ANOVA using SAS for Windows 8.2. Results: Results demonstrate that the fixed combination of Trav/Tim reduced IOP from baseline 7.4–9.4 mmHg (32–37%) compared to 8.4–9.4 mmHg (36–38%) by the concomitant administration of Trav + Tim. Treatment group differences in mean IOP ranged from 0.1 to 1.0 mmHg. A secondary outcome demonstrated that Trav/Tim provides clinically relevant IOP control throughout the day with up to 83% of patients achieving IOP <18 mmHg, with 34% of patients treated with Trav/Tim maintaining IOP <18 mmHg at all nine visits and times throughout the three–month period. Additionally, both Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution and the concomitant administration of TRAVATAN and Timolol 0.5% demonstrated diurnal intraocular pressure control with differences in mean diurnal intraocular pressures ranging from 0.3 to 0.9 mmHg versus 1.1 to 1.3 mmHg, respectively. Conclusions: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution dosed once daily in the morning produces IOP–lowering efficacy that is similar to the concomitant administration of TRAVATAN plus Timolol 0.5%.

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