Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
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|ClinicalTrials.gov Identifier: NCT01309204|
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Open-Angle Glaucoma Ocular Hypertension||Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension Drug: Vehicle Drug: Brinzolamide 1% ophthalmic suspension Drug: Brimonidine tartrate 0.2% ophthalmic solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension
Inactive ingredients used as a placebo for masking purposes
Active Comparator: Brinz+Brim
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
Drug: Brinzolamide 1% ophthalmic suspension
Other Name: AZOPT™
Drug: Brimonidine tartrate 0.2% ophthalmic solution
- Mean Diurnal IOP Change From Baseline at Month 3 [ Time Frame: Baseline (Day 1), Month 3 ]Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309204
|Study Director:||Steve Burmaster, PhD||Alcon Research|