Back to resultsBrinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Brinzolamide 1% ophthalmic suspension
Brimonidine tartrate 0.2% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle glaucoma, Ocular Hypertension, OAG, OHT
Eligibility Criteria
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.
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.
- 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 ocular 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, including severe illness, which would make the subject, 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.
- Concurrent use of glucocorticoid medications administered by any route.
- Other protocol-specified exclusion crtieria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Brinz/Brim
Brinz
Brim
Arm Description
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Outcomes
Primary Outcome Measures
Mean Diurnal IOP Change From Baseline at Month 3
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01310777
Brief Title
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Official Title
Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components 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 3 study drug groups: Brinz/Brim, Brinz, or Brim.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open-Angle glaucoma, Ocular Hypertension, OAG, OHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
771 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brinz/Brim
Arm Type
Experimental
Arm Description
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Arm Title
Brinz
Arm Type
Active Comparator
Arm Description
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Arm Title
Brim
Arm Type
Active Comparator
Arm Description
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1% ophthalmic suspension
Other Intervention Name(s)
AZOPT™
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate 0.2% ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Diurnal IOP Change From Baseline at Month 3
Description
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 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).
Time Frame
Baseline (Day 1), Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
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 ocular 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, including severe illness, which would make the subject, 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.
Concurrent use of glucocorticoid medications administered by any route.
Other protocol-specified exclusion crtieria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Teague, Sr. Clinical Manager
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
We'll reach out to this number within 24 hrs