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
About this trial
This is an interventional treatment trial for Glaucoma
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00347035
First Posted
June 30, 2006
Last Updated
October 25, 2006
Sponsor
Federal University of São Paulo
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
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Primary Completion Date
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Study Completion Date
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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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