Back to resultsStudy to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Concurrent brimonidine 0.2% and 0.5% timolol
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 Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Concurrent Brimonidine 0.2% and 0.5% Timolol
Outcomes
Primary Outcome Measures
Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651612
Brief Title
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients
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
604 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Arm Title
2
Arm Type
Active Comparator
Arm Description
Concurrent Brimonidine 0.2% and 0.5% Timolol
Intervention Type
Drug
Intervention Name(s)
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Other Intervention Name(s)
COMBIGAN™
Intervention Description
Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
Intervention Type
Drug
Intervention Name(s)
Concurrent brimonidine 0.2% and 0.5% timolol
Intervention Description
Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Day 10
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
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.allerganclinicaltrials.com
Description
Link to Clinical Trial Results
Learn more about this trial
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
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