We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00352807
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : October 17, 2007
Sponsor:
Collaborator:
Allergan
Information provided by:
Indiana University

Tracking Information
First Submitted Date  ICMJE July 14, 2006
First Posted Date  ICMJE July 17, 2006
Last Update Posted Date October 17, 2007
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2006)
Bioanalysis of brimonidine concentrations.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients
Official Title  ICMJE Absorption of Brimonidine Ophthalmic Solution in the Aqueous Humor of Cataract Patients.
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 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE Drug: Brimonidine Purite
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 14, 2006)
22
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00352807
Other Study ID Numbers  ICMJE 0501-45
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Indiana University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
PRS Account Indiana University
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP