Back to resultsSafety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
Brimonidine 0.2% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ocular hypertension or glaucoma
- Patient requires IOP-lowering therapy in both eyes
Exclusion Criteria:
- Uncontrolled medical conditions
- Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
0.2% brimonidine ophthalmic solution
Outcomes
Primary Outcome Measures
Intraocular pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00652106
Brief Title
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
432 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
Arm Title
2
Arm Type
Active Comparator
Arm Description
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
Arm Title
3
Arm Type
Active Comparator
Arm Description
0.2% brimonidine ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
Other Intervention Name(s)
COMBIGAN®
Intervention Description
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Intervention Type
Drug
Intervention Name(s)
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
Intervention Description
Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Intervention Type
Drug
Intervention Name(s)
Brimonidine 0.2% ophthalmic solution
Other Intervention Name(s)
ALPHAGAN®
Intervention Description
Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ocular hypertension or glaucoma
Patient requires IOP-lowering therapy in both eyes
Exclusion Criteria:
Uncontrolled medical conditions
Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
El Paso
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.allerganclinicaltrials.com
Description
Link to Clinical Trial Results
Learn more about this trial
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
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