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

NCT01062971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-08-01

Study results available
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Summary

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

Conditions

Interventions

DRUG

dorzolamide-timolol-brimonidine

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 received 1 drop twice a day of either formulations.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo M Baiza-Duran, MD · Clinical Research Department. Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-08-31
Completion
2008-06-30

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062971 on ClinicalTrials.gov