INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Phase 4

Terminated

• Conditions: Glaucoma

• Registration Number: NCT00347035
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Last Update Submitted: 2006-10-25
• Last Update Posted: 2006-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL