Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients
Summary
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)
Description
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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Cataract
Intervention
Brimonidine Purite
Location
Iu Eye at Carmel
Indianapolis
Indiana
United States
46290
Status
Completed
Source
Indiana University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00352807
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cataract
Partial or complete opacity on or in the lens or capsule of one or both eyes, impairing vision or causing blindness. The many kinds of cataract are classified by their morphology (size, shape, location) or etiology (cause and time of occurrence). (Dorland, 27th ed)
Cataract Extraction
The removal of a cataractous CRYSTALLINE LENS from the eye.
Pseudophakia
Presence of an intraocular lens after cataract extraction.
Aphakia, Postcataract
Absence of the crystalline lens resulting from cataract extraction.
Capsule Opacification
Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.
Clinical Trials
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PubMed Articles
Brimonidine Hypersensitivity when Switching Between 0.2% and 0.15% Formulations.
Abstract Purpose: To investigate hypersensitivity rates in patients switched from brimonidine-purite 0.15% to generic brimonidine 0.2%, and to then investigate hypersensitivity rates to re-initiated b...
Effects of brimonidine 0.2%-timolol 0.5% fixed-combination therapy for glaucoma.
PURPOSE: To evaluate the effects of brimonidine 0.2%-timolol 0.5% fixed-combination therapy in the treatment of patients with glaucoma. METHODS: To measure the main treatment effects of a fixed combin...
Measurement of Adherence to Brimonidine Therapy for Glaucoma Using Electronic Monitoring.
PURPOSE: To assess the patient adherence and behavior with brimonidine twice daily (bid) or 3 times daily (tid) in patients used to topical glaucoma medication. PATIENTS AND METHODS: Seventy-five pati...
Adherence with brimonidine in patients with glaucoma aware and not aware of electronic monitoring.
Purpose: To assess the impact of open versus masked adherence monitoring on adherence with topical brimonidine using two different dosing schedules. Methods: Thirty-seven patients with glaucoma...
Effects of brimonidine timolol fixed combination therapy on anterior ocular segment configuration.
PURPOSE: To assess the effects of brimonidine and of brimonidine and timolol fixed combination (BTFC) therapy on the pupil and angle structures in both normal subjects and in open angle glaucoma patie...