Objective: To evaluate the ability of Isopropyl Unoprostone (IU) in maintaining the intraocular pressure of patients previously receiving Timolol Maleate (TM) 0.5%.
Methods: Phase III randomized, double-masked multicentre, parallel-group comparison of IU and TM 0.5%, BID in 39 subjects with chronic open-angle glaucoma or ocular hypertension. Prior to randomization, all subjects were pre-treated with TM 0.5% for 2 weeks. Patients were then randomized to either TM or IU BID for 6 weeks. IOP was measured 2 hours following the morning instillation (approximately at 10:00 AM). Statistical analyses were done with Two-Way ANOVA, ANCOVA and the paired Student's t-test on the intent-to-treat population.
Results: 39 subjects completed the study, 19 on IU and 20 on
TM 0.5%. Mean IOPs prior to the randomization in both groups were not
significantly different (P=0.147). At week 4, mean IOP change from baseline for
subjects randomized to IU was lower than the mean change from
baseline for subjects
randomized to TM 0.5% (-0.48 mmHg vs. +0.81 mmHg, respectively; P = 0.025). At
week 6, differences in mean IOP change from baseline were not statistically
significant between the groups (P=0.606).
Conclusions: At the end of the 6-week treatment period, IU
and TM 0.5% both maintained similar IOP-lowering effect.