AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01484951|
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : April 26, 2013
Last Update Posted : May 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan|
|Study Start Date :||May 2011|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
U.S. FDA Resources
Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops
Other Name: AZARGA®
- Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) [ Time Frame: Baseline, Week 8 ]As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.
- Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy [ Time Frame: Week 8 ]As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.
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): NCT01484951
|United States, Texas|
|Contact Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|