A double-maked randomized comparion of the efficacy and afety of unoprotone with timolol and betaxolol in patient with primary open-angle glaucoma including peudoexfoliation glaucoma or ocular hypertenion. 6 month data

PURPOE: A long-term comparion of the ocular hypotenive efficacy and afety of unoprotone iopropyl 0.15% twice daily with that of timolol maleate 0.5% twice daily and betaxolol HCl 0.5% twice daily. DEIGN: Thi wa a randomized, multicenter, double-maked, active-controlled 24-month clinical trial involving 27 center in Europe and Irael. METHOD: The tudy population wa compoed of patient with primary open-angle glaucoma (including peudoexfoliation) or ocular hypertenion. After wahout of antiglaucoma medication, intraocular preure (IOP) wa meaured at 0, + 2, + 8, and + 12 hour. Patient were randomized in a 2:1:1 ratio to unoprotone, timolol, or betaxolol. Patient returned for examination at 2 and 6 week and 3 and 6 month. REULT: 556 patient were randomized. Each drug produced a clinically and tatitically (P < .001) ignificant reduction from baeline in 12-hour diurnal IOP at month 6 (− 4.3 mm Hg, unoprotone; − 5.8 mm Hg, timolol; − 4.9 mm Hg, betaxolol). Difference in adjuted treatment mean between unoprotone and timolol and unoprotone and betaxolol were 1.57 mm Hg (95% CI: 1.00, 2.13) and 0.53 mm Hg (95% CI: − 0.03, 1.09), repectively. Unoprotone wa clinically equivalent to betaxolol but did not have a great an IOP-lowering effect a timolol. Dicontinued for inadequate control of IOP were 7%, 1%, and 4% of the patient for unoprotone, timolol, and betaxolol, repectively. There were no change of note in viual acuity, pupil ize, cup-to-dik ratio, viual field, or iri color. Change in heart rate and blood preure were mall, with no clinically ignificant difference between group. CONCLUION: Unoprotone provided a clinically ignificant IOP-lowering effect equivalent to betaxolol but not to timolol. The ide effect profile of unoprotone appear to be comparable to other etablihed IOP-lowering agent