Abstract
Abstract: :
Purpose: To measure IOP-lowering efficacy of h.s. dosed TRAVATAN® (travoprost 0.004%) for a period of 36-hours in open-angle glaucoma (OAG) patients and to study the duration of the IOP reduction up to 3.5 days without further dosing. Methods: There were 21 open-angle glaucoma patients enrolled in this open-label study of TRAVATAN®. Entry IOP was restricted to 24-36 mm Hg at 8 AM and 21-36 mm Hg at 12 PM. After washout, baseline pressures were assessed every four hours for 24 hours using a Perkins tonometer. TRAVATAN® was then dosed for two weeks. At week 2, IOPs were taken before the last 8 PM dose and then every 4 hours for 36 hours. Two additional IOP measurements were made at 8 AM visits (days 2.5 and 3.5) following the last dose. Results: IOP change from baselines were statistically significant (p≤0.0001) at all time points following the final dose. During this period, average changes from baselines were greatest at the 8 AM visits (from -10.2 2.5 to -11.2 2.8 mm Hg) and the noon visit (-10.5 3.2 mm Hg). Change from baseline at 4 PM was -9.7 4.0 mm Hg and from -8.1 2.0 to -8.7 2.7 mm Hg at 8 PM visits. Lowest baseline pressures were measured at 8 PM (21.4 2.2 mm Hg) midnight (19.6 2.5 mm Hg), and 4 AM (21.6 2.5 mm Hg) with corresponding smallest change from baseline at the midnight and 4 AM visits (from -4.3 to -6.5 mm Hg). Mean IOP change from baseline at 2.5 days following the final dose was -7.2 ±3.2 mm Hg and -6.6 ±3.5 mm Hg at 3.5 days. Mean IOPs were < 16 mm Hg at 8/10 visits and <18 mm Hg at all visits during the initial 36 hour period and less than 19.5 mm Hg at the subsequent 8 AM visits without further dosing. Conclusion: TRAVATAN ® administration produced significant reductions in IOP from diurnally adjusted baselines at all points. Greatest change from baseline was observed at 8 AM (-11.2 mm Hg) with least change between midnight to 4 AM. IOP reductions ≷6 mm Hg were maintained up to 3.5 days without additional dosing.
Keywords: 514 pharmacology • 390 drug toxicity/drug effects • 349 circadian rhythms