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Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
brimonidine
Sponsored by
Allergan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ocular hypertension or glaucoma in both eyes currently treated with brimonidine requires IOP-lowering therapy in both eyes Exclusion Criteria: uncontrolled systemic disease known allergy or sensitivity to brimonidine

Sites / Locations

    Outcomes

    Primary Outcome Measures

    lowering of intraocular pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    May 27, 2011
    Sponsor
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00168363
    Brief Title
    Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Allergan

    4. Oversight

    5. Study Description

    Brief Summary
    This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    207 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    brimonidine
    Primary Outcome Measure Information:
    Title
    lowering of intraocular pressure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ocular hypertension or glaucoma in both eyes currently treated with brimonidine requires IOP-lowering therapy in both eyes Exclusion Criteria: uncontrolled systemic disease known allergy or sensitivity to brimonidine

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18534052
    Citation
    Cantor LB, Safyan E, Liu CC, Batoosingh AL. Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial. Curr Med Res Opin. 2008 Jul;24(7):2035-43. doi: 10.1185/03007990802199287. Epub 2008 Jun 4.
    Results Reference
    derived
    Links:
    URL
    http://www.allerganclinicaltrials.com
    Description
    Link to Clinical Trial Results

    Learn more about this trial

    Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

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