Back to resultsClinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
dorzolamide-timolol-brimonidine
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Open-angle glaucoma, Ocular hypertension, POAG, Treatment
Eligibility 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.
Sites / Locations
- Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
IOP Dorzolamide-Timolol-Brimonidine group
IOP dorzolamide-timolol group
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01062971
First Posted
February 2, 2010
Last Updated
June 6, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
1. Study Identification
Unique Protocol Identification Number
NCT01062971
Brief Title
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
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 Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratorios Sophia S.A de C.V.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Open-angle glaucoma, Ocular hypertension, POAG, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
IOP Dorzolamide-Timolol-Brimonidine group
Arm Title
B
Arm Type
Active Comparator
Arm Description
IOP dorzolamide-timolol group
Intervention Type
Drug
Intervention Name(s)
dorzolamide-timolol-brimonidine
Other Intervention Name(s)
Krytantek Ofteno, Cosopt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
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 Outcome Measure Information:
Title
Number of Adverse Events
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo M Baiza-Duran, MD
Organizational Affiliation
Clinical Research Department. Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
City
Montemorelos
State/Province
Nuevo Leon
ZIP/Postal Code
67500
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
We'll reach out to this number within 24 hrs