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Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients
This study has been completed.
First Received: July 14, 2006   Last Updated: October 16, 2007   History of Changes
Sponsors and Collaborators: Indiana University School of Medicine
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

MedlinePlus related topics: Cataract
Drug Information available for: Brimonidine Brimonidine tartrate
U.S. FDA Resources
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.

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Bioanalysis of brimonidine concentrations.

Estimated Enrollment: 22
Study Start Date: February 2005
Estimated Study Completion Date: December 2005
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 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
Criteria

Inclusion Criteria:

  • All subjects must:

    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:

  • No subject may:

    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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352807

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
Sponsors and Collaborators
Indiana University School of Medicine
Allergan
Investigators
Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
  More Information

No publications provided

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

Keywords provided by Indiana University:
Cataract

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Eye Diseases
Cataract
Lens Diseases
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Brimonidine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009