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Sponsors and Collaborators: |
Indiana University School of Medicine Allergan |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00352807 |
The purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite® (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.Study hypothesis: The aqueous humor concentration 45 minutes following dosing of 0.1% Brimonidine Purite™ (pH 7.8) is comparable with 0.15% Brimonidine Purite® (pH 7.2)
Condition | Intervention |
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Cataract |
Drug: Brimonidine Purite |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-availability Study |
Official Title: | Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients. |
Estimated Enrollment: | 22 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2005 |
The purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% Brimonidine Purite™ (pH 7.8) or with 0.15% Brimonidine Purite® (pH 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All subjects must:
Exclusion Criteria:
No subject may:
United States, Indiana | |
Iu Eye at Carmel | |
Indianapolis, Indiana, United States, 46290 | |
University Hospital | |
Indianapolis, Indiana, United States, 46202 | |
Veterans Affairs Medical Center | |
Indianapolis, Indiana, United States, 46202 | |
Wishard Memorial Hospital | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Louis B Cantor, MD | IUPUI/Clarian |
Study ID Numbers: | 0501-45 |
Study First Received: | July 14, 2006 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00352807 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cataract |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Eye Diseases Cataract |
Lens Diseases Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Brimonidine |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Eye Diseases Physiological Effects of Drugs Lens Diseases |
Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Therapeutic Uses Cataract Brimonidine |