INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Federal University of São Paulo

Status and phase

Terminated

Phase 4

Conditions

Glaucoma

Treatments

Drug: brimonidine

Study type

Interventional

Funder types

Other

Identifiers

NCT00347035

CEP 0771/04

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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