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

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: dorzolamide-timolol-brimonidine

• Registration Number: NCT01062971
• Lead Sponsor: Laboratorios Sophia S.A de C.V.

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2006-02
• Primary Completion: 2007-08
• Study Completion: 2008-06
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Status Verified: 2018-05
• Results First Submitted: 2018-05-25
• Results First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Results First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
• Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).

Exclusion Criteria

• Clinically relevant ophthalmic or systemic conditions may be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	dorzolamide-timolol-brimonidine	IOP dorzolamide-timolol group
A	dorzolamide-timolol-brimonidine	IOP Dorzolamide-Timolol-Brimonidine group

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	basal (day 1 ) and final (day 60)	the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	basal (day 1 ) and security call (day 75)	the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event.

Trial Locations

Locations (1)

Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos; 🇲🇽 Montemorelos, Nuevo Leon, Mexico