Original ArticlesClinical efficacy and safety of brinzolamide (Azopt™), a new topical carbonic anhydrase inhibitor for primary open-angle glaucoma and ocular hypertension☆
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,
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This study was sponsored and financed by Alcon Laboratories Inc.
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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.