INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

This study has been terminated.

First Received: June 30, 2006 Last Updated: October 25, 2006 History of Changes

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00347035

Purpose

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.

Condition	Intervention	Phase
Glaucoma	Drug: brimonidine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Indomethacin Brimonidine Brimonidine tartrate

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347035

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Aline K Sousa, MD

UNIFESP/EPM Federal University of São Paulo

More Information

No publications provided

Study ID Numbers:	CEP 0771/04
Study First Received:	June 30, 2006
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00347035 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents
Gout Suppressants
Adrenergic Agonists
Tocolytic Agents
Glaucoma
Sensory System Agents
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Adrenergic alpha-Agonists
Eye Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Brimonidine
Ocular Hypertension

ClinicalTrials.gov processed this record on February 08, 2010