Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension

PURPOSE: This study evaluated the safety and intraocular pressure-lowering efficacy of two concentrations of travoprost (0.0015% and 0.004%) compared with latanoprost 0.005% and timolol 0.5% in patients with open,angle glauco ma or ocular hypertension. METHODS: Eight hundred one patients with open-angle glaucoma or ocular hype rtension were randomly assigned to travoprost 0.0015%, travoprost 0.004%, l atanoprost 0.005%, or timolol 0.5%. The efficacy and safety of travoprost ( 0.0015% and 0.004%) daily was compared with latanoprost daily and timolol t wice daily for a period of 12 months. RESULTS: Travoprost was equal or superior to latanoprost and superior to ti molol with mean intraocular pressure over visits and time of day ranging fr om 17.9 to 19.1 mm Hg (travoprost 0.0015%), 17.7 to 19.1 mm Hg (travoprost 0.004%), 18.5 to 19.2 mm Hg (latanoprost), and 19.4 to 20.3 mm Hg (timolol) . For all visits pooled, the mean intraocular pressure at 4 Pm for travopro st was 0.7 mm Hg (0.0015%, P = .0502) and 0.8 rum Hg (0-004%, P = .0191) lo wer than for latanoprost. Travoprost 0.004% was more effective than latanop rost and timolol in reducing intraocular pressure in black patients by up t o 2.4 mm Hg (versus latanoprost) and 4.6 mm Hg (versus timolol). Based on a criterion of 30% or greater intraocular pressure reduction from diurnal ba seline or intraocular pressure 17 mm Hg or less, travoprost 0.0015% and 0.0 04% had an overall response to treatment of 49.3% and 54.7%, respectively, compared with 49.6% for latanoprost and 39.0% for timolol. Iris pigmentatio n change was observed in 10 of 201 of patients (5.0%) receiving travoprost 0.0015%, six of 196 of patients (3.1%) receiving travoprost 0.004%, 10 of 1 94 of patients (5.2%) receiving latanoprost, and none of the patients recei ving timolol (0 of 196). The average ocular hyperemia score was less than 1 on a scale of 0 to 3, indicating that on average patients experienced betw een none/trace and mild for all treatment groups. There were no serious, un expected, related adverse events reported for any therapy. CONCLUSIONS: Travoprost (0.0015% and 0.004%), a highly selective, potent pr ostaglandin F (FP) receptor agonist, is equal or superior to latanoprost an d superior to timolol in lowering intraocular pressure in patients with ope n,angle glaucoma or ocular hypertension. In addition, travoprost 0.004% is significantly better than either latanoprost or timolol in lowering intraoc ular pressure in black patients. Travoprost is safe and generally well tole rated in the studied patient population. (C) 2001 by Elsevier Science Inc. All rights reserved.