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

This study has been completed.
Sponsor:
Information provided by:
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01062971
First received: February 2, 2010
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Drug: dorzolamide-timolol-brimonidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laboratorios Sophia S.A de C.V.:

Primary Outcome Measures:
  • To characterize the intraocular pressure throughout the study period. To evaluate the reduction of intraocular pressure in both groups of treatment. [ Time Frame: basal, and days 1, 2,7,14,15, 30 and 60 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To follow and compare the safety parameters throughout the study period in both groups of treatment. [ Time Frame: basal, and day 1,2,7,15,30 y 60 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: February 2006
Study Completion Date: June 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
IOP Dorzolamide-Timolol-Brimonidine group
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.
Other Names:
  • Krytantek Ofteno
  • Cosopt
Active Comparator: B
IOP dorzolamide-timolol group
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.
Other Names:
  • Krytantek Ofteno
  • Cosopt

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062971

Locations
Mexico
Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
Montemorelos, Nuevo Leon, Mexico, 67500
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
Study Director: Leopoldo M Baiza-Duran, MD Clinical Research Department. Laboratorios Sophia S.A de C.V.
  More Information

No publications provided

Responsible Party: Leopoldo Baiza-Duran, Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01062971     History of Changes
Other Study ID Numbers: SOPHIA-PRO-122
Study First Received: February 2, 2010
Last Updated: February 3, 2010
Health Authority: Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health

Keywords provided by Laboratorios Sophia S.A de C.V.:
Open-angle glaucoma
Ocular hypertension
POAG

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014