Randomized clinical trial of latanoprost and unoprostone in patients with elevated intraocular pressure.

Abstract Purpose To compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost 0.005% once daily with that of unoprostone 0.15% twice daily for patients with primary open-angle glaucoma or ocular hypertension. Design Randomized clinical trial. Methods In a prospective, 8-week, investigator-masked, parallel-group study conducted at numerous centers in the United States, 165 previously treated patients with IOP ≥ 25 mm Hg in one or both eyes after washout were randomly assigned to receive either latanoprost 0.005% once daily in the evening or unoprostone 0.15% twice daily. Observations procedures were Goldmann applanation tonometry, best-corrected visual acuity, slit lamp biomicroscopy, and ophthalmoscopy. The main outcome measure was change in the mean of the IOPs measured at 8:00 am, 12 noon, and 4:00 pm between baseline (before treatment) and after 8 weeks of treatment. Results The change in the mean ± SD of the IOPs measured at 8:00 am, 12 noon, and 4:00 pm was −7.2 ± 3.2 mm Hg (28%) for latanoprost (25.3 ± 2.8 mm Hg at baseline to 18.2 ± 2.8 mm Hg at 8 weeks) and −3.9 ± 2.6 mm Hg (15%) for unoprostone (25.5 ± 3.3 mm Hg at baseline to 21.6 ± 4.0 mm Hg; P ≤ .001. No serious adverse event related to either medication was reported. Conclusions Over an 8-week period, latanoprost 0.005% once daily lowered IOP more than unoprostone 0.15% twice daily in patients with elevated IOP. Both agents were safe and well tolerated.