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Abstract #12388 Published in IGR 7-2
Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension
Schuman JS; Katz GJ; Lewis RA; Henry JC; Mallick S; Wells DT; Sullivan EK; Landry TA; Bergamini MV; Robertson SMAmerican Journal of Ophthalmology 2005; 140: 242
PURPOSE: To compare the efficacy of a fixed combination of travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months. DESIGN: Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial. METHODS: Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mmHg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer. RESULTS: Mean IOP ranged from 16.2 to 17.4 mmHg with the combination travoprost/timolol compared with 15.4 to 16.8 mmHg in the concomitant travoprost + timolol group, from baselines of 23.1 to 25.6 mmHg and 22.9 to 25.0 mmHg, respectively. The fixed combination of travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with travoprost/timolol combination and concomitant travoprost + timolol, respectively. CONCLUSIONS: Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant travoprost + timolol. This study demonstrates that the fixed combination of travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.
Dr. J.S. Schuman, UPMC Eye Center, Eye and Ear Institute, Pittsburgh, PA, USA
Classification:
11.4 Prostaglandins (Part of: 11 Medical treatment)