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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 patientswith open-angle glaucoma or ocular hypertensionwere 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 mmHg to 3.3 mmHg 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 andwell tolerated with an incidence of adverse eventswas 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.
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% DESIGN: Randomized multicenter, double-masked, active-controlled, parallel group study. METHODS: Two hundred sixty-three patients with open-angle glaucoma or ocular hypertensionwere randomized to Traff 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 mmHg to 3.3 mmHg 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 significa nt 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 andwell 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.