A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Phase 3 Completed 437 enrolled Alcon Research

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Timeline

Start: 2005-10
Primary completion: 2007-08
Completion: 2007-08

Outcome

Met primary endpoint

paper within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. PMID 19365194 ↗

Publications

Results Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brinzolamide	Small molecule	10 mg/ml	Topical
Comparator	Dorzolamide	Small molecule	20 mg/ml	Topical
Comparator	Timolol	Other / unclassified	5 mg/ml	Topical