Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil
This study has been terminated.
(Low recruitment rate)
Information provided by (Responsible Party):
First received: January 18, 2012
Last updated: August 15, 2013
Last verified: August 2013
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Brazil|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
|Study Start Date:||March 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Drug: Brinzolamide/timolol maleate fixed combination
Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
Other Name: AZARGA®
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