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

Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062971
• Other study ID #: SOPHIA-PRO-122
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2018
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Mexico	Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos	Montemorelos	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.	basal (day 1 ) and final (day 60)
Secondary	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.	basal (day 1 ) and security call (day 75)