Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide

Status Completed

Clinical Trial Summary

To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

Clinical Trial Description

This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01062971
Study type	Interventional
Source	Laboratorios Sophia S.A de C.V.
Contact
Status	Completed
Phase	Phase 2
Start date	February 2006
Completion date	June 2008

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