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

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ClinicalTrials.gov Identifier: NCT01062971
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : May 1, 2018
Sponsor:
Information provided by:
Laboratorios Sophia S.A de C.V.

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : February 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : June 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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

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