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WGA Rescources

Abstract #18353 Published in IGR 3-3

Evaluation of travoprost as adjunctive therapy in patients with uncontrolled intraocular pressure while using timolol 0.5%

Orengo-Nania S; Landry T; Von Tress M; Silver L; Weiner A; Davis AA
American Journal of Ophthalmology 2001; 132: 860-868


PURPOSE: To evaluate the intraocular pressure-lowering efficacy and safety of travoprost 0.0015% and 0.004%, dosed daily in the evening compared with vehicle, in patients with open-angle glaucoma or ocular hypertension, whose intraocular pressure (IOP) was not adequately controlled on timolol 0.5% twice daily (twice daily). METHODS: Subjects who qualified at screening began a run-in period dosing timolol twice daily for three weeks. If the subjects had an IOP of 24-36 mmHg at 8 a.m. and 21-36 mmHg at 10 a.m. and 4 p.m. in at least one eye on timolol, they were randomized to one of two concentrations of travoprost (0.0015% or 0.004%) or vehicle solution every day and were followed for six months. Four hundred and twenty-six subjects were randomized. The mean IOP at 8 a.m., 10 a.m., and 4 p.m. in the patient's eye with the higher IOP was used for the analysis. RESULTS: Mean baseline values (25 mmHg) for subjects at eligibility (while maintained on timolol) were not significantly different (p < 0.0001) among the treatment groups. The IOP was lowered an additional -5.7 to -7.2 mmHg and -5.1 to -6.7 mmHg in the travoprost 0.004% and 0.0015% concentrations, respectively. These changes were significantly (p 0.0001) different from the vehicle group (-1.3 to -2.8 mmHg). The IOP range on treatment at all visit times over the six-month treatment period ranged from 17.9-19.2 mmHg for travoprost 0.004% and 18.3-20.1 mmHg for travoprost 0.0015% compared with 22.4-24.1 mmHg for vehicle. Average hyperemia scores ranged from trace to mild (mean 0.5 on a scale of 0 = none/trace; 1 = mild; 2 = moderate; 3 = severe) for all treatment groups. No iris pigmentation changes were observed in any patient during this study. There were no clinically or statistically significant changes from baseline in visual acuity, ocular cells and flare, fundus parameter, cup-to-disc ratio and visual field between the treatment groups. There were no serious adverse events reported for any treatment group. CONCLUSIONS: Travoprost produced clinically relevant and statistically significant additional IOP reductions from baseline when used adjunctively with timolol in subjects with open-angle glaucoma or ocular hypertension.

Dr S. Orengo-Nania, Baylor College of Medicine, Houston, TX, USA


Classification:

11.4 Prostaglandins (Part of: 11 Medical treatment)



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