Trials / Completed
CompletedNCT01309204
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,184 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.
Detailed description
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension | |
| DRUG | Vehicle | Inactive ingredients used as a placebo for masking purposes |
| DRUG | Brinzolamide 1% ophthalmic suspension | |
| DRUG | Brimonidine tartrate 0.2% ophthalmic solution |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2011-03-07
- Last updated
- 2014-04-07
- Results posted
- 2014-04-07
Source: ClinicalTrials.gov record NCT01309204. Inclusion in this directory is not an endorsement.