Skip to main content
OpenTrials
Completed

NCT Number: NCT01062971

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos

Montemorelos, Nuevo León, 67500, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dorzolamide-timolol-brimonidine

Drug

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.

Other names: Krytantek Ofteno, Cosopt

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: basal (day 1 ) and final (day 60)

    the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.

Secondary outcomes

  1. Number of Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Feb 4, 2010
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.