- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00652106
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
April 1, 2008 updated by: Allergan
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
432
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
El Paso, Texas, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
|
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Other Names:
|
Active Comparator: 2
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
|
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)
|
Active Comparator: 3
0.2% brimonidine ophthalmic solution
|
Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraocular pressure (IOP)
Time Frame: Day 28
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
March 1, 2004
Study Completion (Actual)
March 1, 2004
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 3, 2008
Study Record Updates
Last Update Posted (Estimate)
April 3, 2008
Last Update Submitted That Met QC Criteria
April 1, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Timolol
- Brimonidine Tartrate
- Ophthalmic Solutions
- Pharmaceutical Solutions
Other Study ID Numbers
- 190342-019T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
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AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleMexico, Colombia
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AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleBrazil
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AllerganCompletedOcular Hypertension | Open-Angle GlaucomaCanada
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Bp Consulting, IncAllerganCompletedOcular Hypertension | Open-Angle GlaucomaCanada
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AllerganCompletedOcular Hypertension | GlaucomaUnited States
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AllerganCompletedOcular Hypertension | GlaucomaChina
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AllerganCompletedGlaucomaUnited States
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AllerganTerminatedGlaucoma, Angle-ClosureThailand
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AllerganCompletedOcular Hypertension | GlaucomaUnited States