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

Laboratorios Sophia S.A de C.V.124 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

124

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

dorzolamide-timolol-brimonidineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Montemorelos, Nuevo León, Mexico

Outcomes

Primary Outcomes

Intraocular Pressure (IOP)

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

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

Secondary Outcomes

Number of Adverse Events

the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event.

Time frame: basal (day 1 ) and security call (day 75)

Data from ClinicalTrials.gov

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