The long-term afety and efficacy of brinzolamide 1.0% (Azopt) in patient with primary open-angle glaucoma or ocular hypertenion

PURPOE: Oral carbonic anhydrae inhibitor ued to treat glaucoma have ignificant ytemic ide effect. Brinzolamide 1.0%, a new topical ocular carbonic anhydrae inhibitor, i effective apparently without ignificant ytemic ide effect. Thi tudy wa performed to etablih the long-term afety and efficacy of brinzolamide 1.0% two and three time daily for primary open-angle glaucoma and ocular hypertenion. METHOD: An 18-month, multicenter, double-maked, parallel, controlled tudy wa conducted. Patient were randomized to brinzolamide two or three time daily or timolol 0.5% twice daily in a 2:2:1 ratio (n = 150, 153, and 75, repectively). Intraocular preure wa meaured at 8:00 at eligibility and month 1, 3, 6, 9, 12, 15, and 18. Efficacy wa baed on intraocular preure reduction from baeline. afety wa alo evaluated. REULT: All regimen produced clinically relevant and tatitically ignificant (P< .05) intraocular preure reduction from baeline. Mean change in intraocular preure trough meaurement ranged from −2.7 to −3.9 mm Hg with brinzolamide twice-daily doing and −2.8 to −3.8 mm Hg three time daily doing compared with −4.7 to −5.6 mm Hg with timolol. The intraocular preure reduction with brinzolamide two and three time daily were clinically and tatitically equivalent. One hundred forty-four patient were dicontinued from the tudy after randomization with the mot common reaon being the occurrence of an advere event (46), inadequate intraocular preure control (23), patient deciion unrelated to tudy medication (11), lot to follow-up (16), and noncompliance (9). Advere event were noneriou and reolved without equelae. There were no clinically relevant change in afety parameter. Brinzolamide produced le ocular dicomfort (burning/tinging) than timolol, and total carbonic anhydrae inhibition level remained below that known to caue ytemic ide effect. CONCLUION: Brinzolamide produced ignificant and equivalent reduction in intraocular preure when doed two and three time daily for 18 month. Brinzolamide wa afe and well tolerated by patient, with minimal ocular dicomfort.