Status:
COMPLETED
Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Allergan
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 un...
Detailed 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 un...
Eligibility Criteria
Inclusion
- All subjects must:
- Be willing and able to provide written Informed Consent
- Be able and willing to follow instructions and likely to complete the entire course of the study.
- Be male or female of any race at least 18 years of age.
- Have visually significant cataract for which they have elected to undergo cataract surgery.
Exclusion
- No subject may:
- Known allergy or sensitivity to the study medication or its components
- Contraindications to brimonidine therapy: concurrent use of monoamine oxidase (MAO) inhibitor therapy
- 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.
- Any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months.
- Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears.
- 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.
- Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
- Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception.
- 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)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00352807
Start Date
February 1 2005
End Date
December 1 2005
Last Update
October 17 2007
Active Locations (4)
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1
University Hospital
Indianapolis, Indiana, United States, 46202
2
Veterans Affairs Medical Center
Indianapolis, Indiana, United States, 46202
3
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
4
Iu Eye at Carmel
Indianapolis, Indiana, United States, 46290