Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Brinzolamide 1% ophthalmic suspension; Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension; Drug: Brimonidine tartrate 0.2% ophthalmic solution; Drug: Vehicle

• Registration Number: NCT01309204
• Lead Sponsor: Alcon Research

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-07
• Study Start: 2011-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2014-01-24
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-07
• Last Update Submitted: 2014-03-07
• Results First Posted: 2014-04-07
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1184

Inclusion Criteria

• Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
• Meet qualifying IOP entry criteria.
• Able to understand and sign an informed consent form.
• Other protocol-specified inclusion criteria may apply.

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Exclusion Criteria

• Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• Severe central visual field loss.
• Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
• Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
• Chronic, recurrent or severe inflammatory eye disease.
• Ocular trauma within the preceding 6 months.
• Ocular infection or inflammation within the preceding 3 months.
• Clinically significant or progressive retinal disease.
• Other ocular pathology.
• Intraocular surgery within the 6 months prior to entry.
• Ocular laser surgery within the 3 months prior to entry.
• Any abnormality preventing reliable applanation tonometry.
• Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
• Recent use of high-dose (>1 gram daily) salicylate therapy.
• Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
• Other protocol-specified exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brinz+Brim	Brinzolamide 1% ophthalmic suspension	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.
Brinz+Brim	Brimonidine tartrate 0.2% ophthalmic solution	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.
Brinz/Brim	Vehicle	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.
Brinz/Brim	Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension	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.

Primary Outcome Measures

Name	Time	Method
Mean Diurnal IOP Change From Baseline at Month 3	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).