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Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00352807
First Posted: July 17, 2006
Last Update Posted: October 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Indiana University
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients.

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352807


Locations
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
Veterans Affairs Medical Center
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Iu Eye at Carmel
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Indiana University School of Medicine
Allergan
Investigators
Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00352807     History of Changes
Other Study ID Numbers: 0501-45
First Submitted: July 14, 2006
First Posted: July 17, 2006
Last Update Posted: October 17, 2007
Last Verified: October 2007

Keywords provided by Indiana University:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Brimonidine Tartrate
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs