The Safety and Efficacy of Travoprost 0.004%/Timolol 0.5% Fixed Combination Ophthalmic Solution - 18/08/11
, Silvia Orengo-Nania, MD b, Brian E. Flowers, MD c, John Samples, MD d, Sushanta Mallick, PhD e, Theresa A. Landry, PhD e, Michael V.W. Bergamini, PhD e
Inquiries to Howard Barnebey, MD, University of Washington, Ophthalmology, Specialty Eye Care Center, Boren Avenue, Suite 1030, Seattle, WA 98004; fax: (206) 447-8164Résumé |
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.
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| This study was supported by Alcon Research Ltd., Fort Worth, Texas. |
Vol 140 - N° 1
P. 1.e1-1.e8 - juillet 2005 Retour au numéro
- Visual Dysfunction After Panretinal Photocoagulation in Patients With Severe Diabetic Retinopathy and Good Vision
- Masahiko Shimura, Kanako Yasuda, Toru Nakazawa, Makoto Tamai
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