Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
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ClinicalTrials.gov Identifier: NCT00652106 |
Recruitment Status :
Completed
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
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Condition or disease | Intervention/treatment | 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 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 432 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | March 2004 |
Actual Study Completion Date : | March 2004 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
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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)
Other Name: COMBIGAN® |
Active Comparator: 2
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
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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) |
Active Comparator: 3
0.2% brimonidine ophthalmic solution
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Drug: Brimonidine 0.2% ophthalmic solution
Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
Other Name: ALPHAGAN® |
- Intraocular pressure (IOP) [ Time Frame: Day 28 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652106
United States, Texas | |
El Paso, Texas, United States |
Study Director: | Medical Director | Allergan |
Responsible Party: | Therapeutic Area Head, Allergan, Inc. |
ClinicalTrials.gov Identifier: | NCT00652106 |
Other Study ID Numbers: |
190342-019T |
First Posted: | April 3, 2008 Key Record Dates |
Last Update Posted: | April 3, 2008 |
Last Verified: | April 2008 |
Glaucoma Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Brimonidine Tartrate Pharmaceutical Solutions Ophthalmic Solutions Adrenergic beta-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |