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Abstract #12384 Published in IGR 7-2
The safety and efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution
Barnebey HS; Orengo-Nania S; Flowers BE; Samples J; Mallick S; Landry TA; Bergamini MVAmerican Journal of Ophthalmology 2005; 140: 1-7
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 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 mmHg to 2.4 mmHg 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.
Dr. H.S. Barnebey, University of Washington, Ophthalmology, Specialty Eye Care Center, Seattle, WI 98004, USA. h.barnebey@verizon.net
Classification:
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.4 Prostaglandins (Part of: 11 Medical treatment)