Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients
NCT ID: NCT00352807
Last Updated: 2007-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2005-02-28
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Brimonidine Purite
Eligibility Criteria
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Inclusion Criteria
1. Be willing and able to provide written Informed Consent
2. Be able and willing to follow instructions and likely to complete the entire course of the study.
3. Be male or female of any race at least 18 years of age.
4. Have visually significant cataract for which they have elected to undergo cataract surgery.
Exclusion Criteria
1. Known allergy or sensitivity to the study medication or its components
2. Contraindications to brimonidine therapy: concurrent use of monoamine oxidase (MAO) inhibitor therapy
3. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.
4. Any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months.
5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears.
6. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior chamber which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.
7. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
8. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception.
9. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study such as, significant cardiovascular disease, hepatic or renal impairment, depression, Raynaud's, orthostatic hypotension; uncontrolled high blood pressure. or concomitant use of other potential CNS depressants and tricyclics, (Amendment 1, May 25, 2005)
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Indiana University School of Medicine
OTHER
Principal Investigators
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Louis B Cantor, MD
Role: PRINCIPAL_INVESTIGATOR
IUPUI/Clarian
Locations
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University Hospital
Indianapolis, Indiana, United States
Veterans Affairs Medical Center
Indianapolis, Indiana, United States
Wishard Memorial Hospital
Indianapolis, Indiana, United States
Iu Eye at Carmel
Indianapolis, Indiana, United States
Countries
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References
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PK-02-P027 Relative ocular bioavailability of 0.2% Alphagan and 0.15% Brimonidine-BAK to that of 0.15% Alphagan P in female albino rabbits. Allergan 2002.
PK-02-P041 Comparison of ocular and systemic bioavailability of three 0.10% brimonidine purite formulations to that of 0.15% Alphagan P in albino rabbits. Allergan 2002.
Other Identifiers
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0501-45
Identifier Type: -
Identifier Source: org_study_id