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INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Primary Purpose

Glaucoma

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
brimonidine
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: primary open-angle glaucoma or ocular hypertension patients with the following criteria: 18 years of age or older, insufficient response to monotherapy with timolol maleate 0,5%, and adequate compliance in follow-up treatment Exclusion Criteria: hypersensitivity to eyedrop solutions, insufficient compliance in follow-up treatment, pregnancy or childbearing potential.

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    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2006
    Last Updated
    October 25, 2006
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00347035
    Brief Title
    INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE
    Official Title
    INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2006
    Overall Recruitment Status
    Terminated
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    5. Study Description

    Brief Summary
    Purpose: To evaluate the influence of the nonsteroidal anti-inflammatory indomethacin on the brimonidine intraocular pressure (IOP) lowering effect. Methods: A randomized double-masked study was carried out. Patients medicated with timolol maleate 0,5% and needed complementary medication were random allocated into two groups: (a) brimonidine tartarate 0,15% and indomethacin 1% or (b) brimonidine tartarate and placebo (balanced saline solution). If patient's both eyes were eligible, they were allocated to the same group. IOP was measured at two weeks, one month and two months after study beginning. The mean IOP of the eyes was used for analyzes, in the case of two eligible eyes. For statistical analyzes repeated measures analysis was used.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    brimonidine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Eligibility Criteria
    Inclusion Criteria: primary open-angle glaucoma or ocular hypertension patients with the following criteria: 18 years of age or older, insufficient response to monotherapy with timolol maleate 0,5%, and adequate compliance in follow-up treatment Exclusion Criteria: hypersensitivity to eyedrop solutions, insufficient compliance in follow-up treatment, pregnancy or childbearing potential.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aline K Sousa, MD
    Organizational Affiliation
    UNIFESP/EPM Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

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