Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Allergan |
---|---|
Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00652106 |
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
Condition | Intervention | Phase |
---|---|---|
Glaucoma Ocular Hypertension |
Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution Drug: Brimonidine 0.2% ophthalmic solution |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 432 |
Study Start Date: | June 2003 |
Study Completion Date: | March 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
|
Drug: 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)
|
2: Active Comparator
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
|
Drug: 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)
|
3: Active Comparator
0.2% brimonidine ophthalmic solution
|
Drug: Brimonidine 0.2% ophthalmic solution
Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 190342-019T |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00652106 |
Health Authority: | United States: Food and Drug Administration |
Glaucoma Eye Diseases Vascular Diseases Timolol |
Brimonidine Hypertension Ocular Hypertension |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Adrenergic Agonists Pharmacologic Actions Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents |