Clinical efficacy and safety of brinzolamide (Azopt), a new topical carbonic anhydrase inhibitor for primary open-angle glaucoma and ocular hypertension. Brinzolamide Primary Therapy Study Group.
OBJECTIVE
To determine the intraocular pressure-lowering efficacy and safety of brinzolamide 1.0%, compared with dorzolamide 2.0% and timolol 0.5%.


METHODS
A multicenter, double-masked, prospective, parallel-group study was conducted to compare brinzolamide 1.0%, administered two and three times a day, dorzolamide 2.0% three times a day, and timolol 0.5% twice a day in 572 patients with primary open-angle glaucoma or ocular hypertension. The primary end point was diurnally corrected intraocular pressure reduction from baseline, evaluated at both peak and trough times during a 3-month period.


RESULTS
Mean intraocular pressure changes after twice daily (-3.8 to -5.7 mm Hg) and three times daily (-4.2 to -5.6 mm Hg) dosing with brinzolamide 1.0% were statistically equivalent (confidence limit < or = 1.5 mm Hg) to each other and also to dorzolamide 2.0% three times a day (-4.3 to -5.9 mm Hg). The range of intraocular pressure change with timolol 0.5% twice daily was -5.2 to -6.3 mm Hg. Clinically relevant intraocular pressure changes (reduction > or = 5 mm Hg or intraocular pressure < or = 21 mm Hg) were observed in up to 75.7% of patients taking brinzolamide twice daily and in up to 80.1% taking brinzolamide three times daily. Treatment with brinzolamide 1.0% was safe, comfortable, and well tolerated. The incidence of ocular discomfort (burning and stinging) on instillation of brinzolamide (twice daily, 1.8%; three times daily, 3.0%) was significantly less (P = .000) compared with treatment with dorzolamide (16.4%).


CONCLUSIONS
Brinzolamide 1.0% produced clinically relevant intraocular pressure reductions in substantial numbers of patients. Brinzolamide's effectiveness equaled that of dorzolamide 2.0% and it produced less ocular discomfort (burning and stinging) on instillation.
Silver
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Alcon Laboratories Inc, Fort Worth, Texas 76134, USA. lewis.silver@alconlabs.com
D000287:Administration, Topical; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D000368:Aged; D002257:Carbonic Anhydrase Inhibitors / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012449:Safety; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D013843:Thiazines / Q000008:administration & dosage* / Q000009:adverse effects; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects; D013999:Timolol / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D002257:Carbonic Anhydrase Inhibitors; D009883:Ophthalmic Solutions; D013449:Sulfonamides; D013843:Thiazines; D013876:Thiophenes; D013999:Timolol; C111827:brinzolamide; C062765:dorzolamide