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Sponsored by: |
Allergan |
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Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00811850 |
A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5% and fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions on ocular blood flow as measured by retrobulbar blood flow
Condition | Intervention | Phase |
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Glaucoma |
Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 15 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
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Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
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2: Active Comparator
Fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution
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Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution
1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
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Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Allergan, Inc. ( Medical Affairs Director ) |
Study ID Numbers: | GMA-COM-08-009 |
Study First Received: | December 17, 2008 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00811850 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Eye Diseases Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Carbonic Anhydrase Inhibitors Glaucoma |
Adrenergic beta-Antagonists Adrenergic Antagonists Timolol Anti-Arrhythmia Agents Ocular Hypertension Hypertension Brimonidine Dorzolamide |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Eye Diseases Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions |
Carbonic Anhydrase Inhibitors Glaucoma Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Ocular Hypertension Brimonidine Dorzolamide |