The afety and Efficacy of Travoprot 0.004%/Timolol 0.5% Fixed Combination Ophthalmic olution

Purpoe To compare the afety and intraocular preure (IOP)-lowering efficacy of travoprot 0.004%/timolol 0.5% fixed combination ophthalmic olution (Trav/Tim) to it component travoprot 0.004% ophthalmic olution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic olution (Tim) in patient with open-angle glaucoma or ocular hypertenion. Deign Randomized multicenter, double-maked, active-controlled, parallel group tudy. Method Two hundred ixty-three patient with open-angle glaucoma or ocular hypertenion 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 afety were compared acro treatment group over 3 month. Reult Trav/Tim produced a mean IOP decreae from baeline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a ignificant decreae in mean IOP at each of the nine tudy viit (P ≤ .003). Trav/Tim decreaed mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a ignificant decreae in mean IOP at even of the nine tudy viit (P ≤ .05). The advere event profile for Trav/Tim wa comparable to Trav or Tim alone. Concluion Over the 3 month of treatment, Trav/Tim produced clinically relevant IOP reduction in patient with open-angle glaucoma or ocular hypertenion that were greater than thoe produced by either Trav or Tim alone. The clinical reult that Trav/Tim wa afe and well tolerated with an incidence of advere event wa comparable to the reult of Trav or Tim alone. Trav/Tim provide both more effective IOP reduction than it component and the benefit of once-daily doing.