Back to resultsSafety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
brimonidine/timolol fixed combination
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist or brimonidine therapy
Sites / Locations
Outcomes
Primary Outcome Measures
IOP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332436
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
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
November 2001 (Actual)
Study Completion Date
November 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
586 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
brimonidine/timolol fixed combination
Primary Outcome Measure Information:
Title
IOP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
Patient requires IOP-lowering drug in both eyes
Exclusion Criteria:
Uncontrolled medical condition
Contraindication to beta-adrenoceptor antagonist or brimonidine therapy
Facility Information:
City
Louisville
State/Province
Kentucky
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
We'll reach out to this number within 24 hrs