A randomized double-masked crossover study comparing latanoprost 0.005% with unoprostone 0.12% in patients with primary open-angle glaucoma and ocular hypertension

PURPOSE: To compare the intraocular pressure)-lowering effect and side effe cts of latanoprost 0.005% once daily with unoprostone 0.12% twice daily. METHODS: Sixty patients with primary open-angle glaucoma or ocular hyperten sion were randomized to receive either latanoprost once daily in the evenin g and placebo once daily in the morning, or unoprostone twice dairy in the morning and evening. The study was double masked and followed a crossover d esign with two treatment periods of 1 month separated by a 3-week washout p eriod. The intraocular pressure was measured at g AM and 5 PM on the baseli ne and day 28 visits, and at 9 AM on day 2 and day 14 visits of each treatm ent period. The 9 AM measurement was taken 2 hours and 13 hours after the l ast drop of unoprostone and latanoprost, and the 5 PM measurement was at 10 and 21 hours, respectively, The mean of the measurements was calculated. S afety parameters were also recorded. RESULTS: Fifty-six patients completed both treatment periods and had intrao cular pressure data available for evaluation. After I month of treatment, l atanoprost significantly reduced intraocular pressure (mean +/- SEM) by 6.1 +/- 0.5 mm Hg (P < .001) and unoprostone by 4.2 +/- 0.4 mm Hg (P < .001) a djusted from an overall baseline of 22.3 +/- 0.5 mm Hg and 23.2 +/- 0.4 mm Hg, respectively, The difference of 1.9 mm Hg between treatments was statis tically significant in favor of latanoprost [P =.003, analysis of covarianc e (ANCOVA)]. Unadjusted analysis of responders using the percentage decreas e in intraocular pressure showed that the proportion of responders in the l atanoprost-treated group was greater than in the unoprostone-treated group. Adverse ocular symptoms and findings were mild in both treatment groups. E ye redness and ocular irritation were the most frequently reported events. CONCLUSIONS: Latanoprost once daily was significantly more effective in red ucing intraocular pressure compared with unoprostone twice daily after I mo nth of treatment in patients with primary open-angle glaucoma and ocular hy pertension. Both drugs were well tolerated with few ocular adverse events. (C) 2001 by Elsevier Science Inc. All rights reserved.).