Comparison of the Safety and IOP–Lowering Efficacy of Travoprost 0.004%/Timolol 0.5% Fixed Combination to the Concomitant Administration of Xalatan® and Timolol 0.5%

Abstract

Purpose: : To assess the IOP–lowering efficacy of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (Trav/Tim) vs. the concomitant administration of Xalatan^® and Timolol 0.5% (Xal+Tim) in patients with open–angle glaucoma or ocular hypertension who were previously controlled on Xalatan^® and Timolol 0.5%.

Methods: : Patients dosing with Xalatan and Timolol for at least 30 days and with IOP <18 mmHg at the Screening Visit continued dosing with open–label Xalatan (PM) and Timolol (AM) once–daily in both eyes for 30 days prior to an Eligibility Visit (EV). Patients with IOPs <18 mmHg at 8 AM, 10 AM, 4 PM, and 8 PM at EV were randomized to receive either Trav/Tim (AM) + Vehicle (PM) (n = 79) or Xal (PM) + Tim (AM) (n = 77). On–therapy IOP was assessed at Week 2, Week 6 and Month 3. Safety was assessed via ophthalmic and cardiovascular (pulse, blood pressure) parameters and adverse events. Two–sample t–tests were used to assess treatment–group differences.

Results: : Mean eligibility IOP was similar between groups (p>0.38) at all time–points. No statistically significant differences in mean IOP, mean IOP change from baseline, and mean percent IOP change from baseline were observed between treatment groups at any time point (p>0.21). Up to 92% of patients in the Trav/Tim group and up to 88% of patients in the Xal+Tim group maintained clinically relevant IOP response (IOP <18 mmHg). Ocular hyperemia reported for both groups was similar, 2.5% for Trav/Tim and 2.6% for Xal+Tim. No patients were discontinued from the study due to adverse events.

Conclusions: : Travoprost 0.004%/Timolol 0.5% fixed combination provides continued adequate IOP control in patients who were previously well–controlled on the unfixed combination of Xalatan and Timolol. Once–daily dosing likely increases patient dosing compliance in the long–term treatment of open–angle glaucoma and ocular hypertension.

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