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

This study was presented in part at the Annual Meeting of the American Glaucoma Society, Newport Beach, California, March 2, 2001, and at the Annual Meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, Florida, May 2, 2001.
https://doi.org/10.1016/S0002-9394(01)01177-1Get rights and content

Abstract

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 glaucoma or ocular hypertension.

METHODS: Eight hundred one patients with open-angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.0015%, travoprost 0.004%, latanoprost 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 twice daily for a period of 12 months.

RESULTS: Travoprost was equal or superior to latanoprost and superior to timolol with mean intraocular pressure over visits and time of day ranging from 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 travoprost was 0.7 mm Hg (0.0015%, P = .0502) and 0.8 mm Hg (0.004%, P = .0191) lower than for latanoprost. Travoprost 0.004% was more effective than latanoprost and timolol in reducing intraocular pressure in black patients by up to 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 baseline or intraocular pressure 17 mm Hg or less, travoprost 0.0015% and 0.004% 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 pigmentation 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 194 of patients (5.2%) receiving latanoprost, and none of the patients receiving 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 between none/trace and mild for all treatment groups. There were no serious, unexpected, related adverse events reported for any therapy.

CONCLUSIONS: Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor agonist, is equal or superior to latanoprost and superior to timolol in lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In addition, travoprost 0.004% is significantly better than either latanoprost or timolol in lowering intraocular pressure in black patients. Travoprost is safe and generally well tolerated in the studied patient population.

Section snippets

Patients and methods

This was a randomized, multicenter, double-masked, active-controlled, parallel group study conducted in accordance with the ethical principles set forth in the Declaration of Helsinki. Eight hundred one patients were randomized to one of four treatment groups in an approximate 1:1:1:1 ratio, (travoprost 0.0015%, n = 205; travoprost 0.004%, n = 200; timolol, n = 200; latanoprost, n = 196). The Alcon Biostatistics Department prepared the computer-generated randomization schedule. All patients

Results

Eight hundred one patients were randomized to one of four treatments. All 801 patients were included in the safety analysis. Fourteen patients were excluded from the intent-to-treat analysis because of no on-treatment visit data (travoprost 0.0015% − N = 3; travoprost 0.004% − N = 3; latanoprost − N = 3; timolol − N = 5) resulting in 787 patients in the intent-to-treat data set. Forty-one patients were excluded from the per protocol analysis (travoprost 0.005% − N = 7; travoprost 0.004% − N =

Discussion

When used as primary therapy, the results of this study show that both concentrations of travoprost (0.0015% and 0.004%) were equal or superior to latanoprost and superior to timolol in lowering intraocular pressure at all treatment visits in patients with open-angle glaucoma and ocular hypertension.

In studies carried out in the laser monkey model, reductions in intraocular pressure were observed beginning 2 hours after administration of travoprost and peaked by 12 to 20 hours after dose.5

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This study was supported by Alcon Research, Ltd. Dr Netland was a clinical investigator for this study and has no proprietary interest in travoprost or any other product in this manuscript. Proprietary rights for travoprost are retained by Alcon Research, Ltd, 6201 S. Freeway, Fort Worth, Texas 76134.

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