Back to resultsSafety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brimonidine ophthalmic solution 0.1%
Brimonidine ophthalmic solution 0.2%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Ocular hypertension or glaucoma in both eyes
Exclusion Criteria:
- Uncontrolled systemic disease
- Known allergy or sensitivity to brimonidine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Brimonidine ophthalmic solution 0.1%
Brimonidine ophthalmic solution 0.2%
Outcomes
Primary Outcome Measures
Intraocular pressure (IOP)
Secondary Outcome Measures
IOP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00652483
Brief Title
Safety and Efficacy Study of Brimonidine 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
May 2003 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
September 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 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution 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
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
433 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Brimonidine ophthalmic solution 0.1%
Arm Title
2
Arm Type
Active Comparator
Arm Description
Brimonidine ophthalmic solution 0.2%
Intervention Type
Drug
Intervention Name(s)
Brimonidine ophthalmic solution 0.1%
Intervention Description
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Intervention Type
Drug
Intervention Name(s)
Brimonidine ophthalmic solution 0.2%
Other Intervention Name(s)
ALPHAGAN®
Intervention Description
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Time Frame
Week 2 - Month 3
Secondary Outcome Measure Information:
Title
IOP
Time Frame
Month 6 - Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular hypertension or glaucoma in both eyes
Exclusion Criteria:
Uncontrolled systemic disease
Known allergy or sensitivity to brimonidine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Atlanta
State/Province
Georgia
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 in Patients With Glaucoma or Ocular Hypertension
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