- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01062971
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
June 6, 2019 updated by: Laboratorios Sophia S.A de C.V.
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
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
124
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo Leon
-
Montemorelos, Nuevo Leon, Mexico, 67500
- Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
IOP Dorzolamide-Timolol-Brimonidine group
|
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:
|
Active Comparator: B
IOP dorzolamide-timolol group
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
basal (day 1 ) and final (day 60)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
basal (day 1 ) and security call (day 75)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Leopoldo M Baiza-Duran, MD, Clinical Research Department. Laboratorios Sophia S.A de C.V.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
February 2, 2010
First Submitted That Met QC Criteria
February 3, 2010
First Posted (Estimate)
February 4, 2010
Study Record Updates
Last Update Posted (Actual)
August 1, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Timolol
- Brimonidine Tartrate
- Dorzolamide
Other Study ID Numbers
- SOPHIA-PRO-122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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