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The Safety and Efficacy of Travoprost 0.004%/Timolol 0.5% Fixed Combination Ophthalmic Solution

2005; Elsevier BV; Volume: 140; Issue: 1 Linguagem: Inglês

10.1016/j.ajo.2005.02.043

1879-1891

Howard Barnebey, Silvia Orengo-Nania, Brian Flowers, John R. Samples, Sushanta Mallick, Theresa Landry, Michael V.W. Bergamini,

Neurological Disorders and Treatments

Purpose To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. Design Randomized multicenter, double-masked, active-controlled, parallel group study. Methods Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. Results Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P ≤ .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P ≤ .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. Conclusions Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing. To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. Randomized multicenter, double-masked, active-controlled, parallel group study. Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P ≤ .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P ≤ .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.