A 3-month safety and efficacy study of travoprost 0.004% ophthalmic solution compared with timolol in pediatric patients with glaucoma or ocular hypertension

Abstract

To evaluate efficacy and safety of travoprost in pediatric patients with ocular hypertension or glaucoma and demonstrate its noninferiority to timolol. Patients aged 2months to <18years with glaucoma or ocular hypertension were randomized to receive travoprost (0.004%) or timolol eye drops (0.25% for patients aged 2months to <3years and 0.5% for patients ≥3years old) for 3months in this double-masked, parallel-group study. Intraocular pressure (IOP) was measured and patients were evaluated at 2weeks, 6weeks, and 3months after treatment. Change in IOP from baseline to 3months was the primary endpoint, and the test of noninferiority was based on a margin of +3.0mm Hg using the 95% 2-sided confidence interval of the mean change. Of 157 patients included (mean age, 9.6years), 77 received travoprost and 75 timolol. All patients experienced a significant reduction in IOP in the study eye at 3months: the mean IOP change from baseline was -5.4mm Hg for travoprost; -5.3mm Hg, for timolol. The mean difference between travoprost and timolol at month 3 was -0.1mm Hg (95% CI, -1.5 to 1.4mm Hg). The most common treatment-related adverse events for the travoprost group were ocular hyperemia and eyelash growth. No serious adverse events were reported. This study found travoprost to be noninferior to timolol in lowering IOP in patients with pediatric glaucoma or ocular hypertension. Travoprost was well-tolerated, and no treatment-related systemic adverse events were reported.