Original Articles
Clinical efficacy and safety of brinzolamide (Azopt™), a new topical carbonic anhydrase inhibitor for primary open-angle glaucoma and ocular hypertension

Presented in part at the Annual Meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, Florida, May 13, 1997.
https://doi.org/10.1016/S0002-9394(98)00095-6Get rights and content

Abstract

PURPOSE: 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 ≤ 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 ≥ 5 mm Hg or intraocular pressure ≤ 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.

Section snippets

Patients and methods

This was a multicenter (42 sites), double-masked, prospective, parallel-group, active-controlled trial. Patients enrolled were adults at least 21 years of age of any race and either sex diagnosed with primary open-angle glaucoma (with or without a pseudoexfoliation or pigment dispersion component) or ocular hypertension.

Excluded from this study were patients with only one sighted eye or amblyopia or best-corrected Snellen visual acuity worse than 20/80 in either eye; and those with a history of

Results

A total of 574 patients from 42 investigational sites were randomly assigned to treatment. A total of 572 patients received at least one dose of test medication and were thus included in the safety analyses. Two patients randomly assigned to treatment (one each taking dorzolamide 2.0% and timolol 0.5%) were discontinued from the study before they used the test medication because of personal reasons.

An additional 60 patients randomly assigned to treatment were not evaluable for efficacy and thus

Discussion

The IOP-lowering efficacy of brinzolamide (bid and tid) was demonstrated by both clinically relevant and statistically significant IOP reductions at similar peak (10 am, 2 hours after dose) and trough (8 am, 10 hours after dose) times during the dosing interval. In addition, the IOP-lowering efficacy of brinzolamide bid was further substantiated by IOP reductions at the 6 pm time point (10 hours after dose) that were very similar to those obtained with brinzolamide tid and dorzolamide tid at

The Brinzolamide Primary Therapy Study Group

Robert Allen, MD, Richmond, Virginia; Charles Campbell, MD, Winston-Salem, North Carolina; Carl Camras, MD, University of Nebraska, Omaha, Nebraska; Richard Cohen, MD, Boca Raton, Florida; David Cook, MD, St Joseph, Missouri; Amber Dobler, MD, Fort Worth, Texas; Hans-Joachim Belger, MD, Ahaus, Germany; Alain Bron, MD, Hôpital Général, Dijon, France; Howard Cohn, MD, Paris, France; Jacqueline Collignon, MD, CHU Sart Tilman, Liège, Belgium; José Cunha-Vaz, MD, Clinica Ophthalmologica, Coimbra,

References (9)

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This study was sponsored and financed by Alcon Laboratories Inc.

Participants of the Brinzolamide Primary Therapy Study Group are listed at the end of the article.

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Dr Silver is Senior Director of Clinical Ophthalmology for Alcon Laboratories Inc.

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