INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: brimonidine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s):
Aline K Sousa, MD, Principal Investigator, Affiliation: UNIFESP/EPM Federal University of São Paulo
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.
Clinical Details
Official title: INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Last updated: October 25, 2006
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