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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Collaborator: |
Allergan |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00352807 |
Purpose
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 |
|---|---|
|
Cataract |
Drug: Brimonidine Purite |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00352807 History of Changes |
| Other Study ID Numbers: | 0501-45 |
| Study First Received: | July 14, 2006 |
| Last Updated: | October 16, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Cataract |
|
Cataract Lens Diseases Eye Diseases Brimonidine Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |