Back to resultsA Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
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, Intraocular Pressure, Brinzolamide, Brimonidine
Eligibility Criteria
Inclusion Criteria:
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Severe central vision loss in either eye.
- Any chronic or recurrent inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- Any intraocular surgery within the preceding 6 months.
- Any ocular laser surgery within the preceding 3 months.
- History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
- Other protocol-defined 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 affected eye 3 times a day for 7 days
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Outcomes
Primary Outcome Measures
Mean Ocular Discomfort Score
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01426867
Brief Title
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
Official Title
A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (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 describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.
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, Intraocular Pressure, Brinzolamide, Brimonidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (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 affected eye 3 times a day for 7 days
Arm Title
Brinzolamide
Arm Type
Active Comparator
Arm Description
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
Arm Title
Brimonidine
Arm Type
Active Comparator
Arm Description
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
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 Ocular Discomfort Score
Description
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Time Frame
Week 1
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
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Severe central vision loss in either eye.
Any chronic or recurrent inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Any intraocular surgery within the preceding 6 months.
Any ocular laser surgery within the preceding 3 months.
History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravaughn Williams, OD, MS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
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