Back to resultsThree Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
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 ophthalmic suspension, 1%
Brimonidine tartrate ophthalmic solution, 0.2%
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension, Brinzolamide, Brimonidine, Intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Any form of glaucoma other than open-angle glaucoma.
- Severe central vision loss in either eye.
- 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 such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
- Ocular surgery within the preceding 6 months.
- Ocular laser surgery within the preceding 3 months.
- Any abnormality preventing reliable applanation tonometry.
- Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria 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
Brinzolamide
Brimonidine
Arm Description
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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
NCT01297920
Brief Title
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
Official Title
A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (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 a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/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 the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.
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, Brinzolamide, Brimonidine, Intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1062 (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 3 times a day for 3 months
Arm Title
Brinzolamide
Arm Type
Active Comparator
Arm Description
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
Arm Title
Brimonidine
Arm Type
Active Comparator
Arm Description
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Brinzolamide ophthalmic suspension, 1%
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate ophthalmic solution, 0.2%
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
Description
The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Any form of glaucoma other than open-angle glaucoma.
Severe central vision loss in either eye.
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 such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
Ocular surgery within the preceding 6 months.
Ocular laser surgery within the preceding 3 months.
Any abnormality preventing reliable applanation tonometry.
Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Teague, BS, Sr. Clinical Manager
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
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