Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
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
1 other identifier
interventional
124
1 country
1
Brief Summary
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedResults Posted
Study results publicly available
August 1, 2019
CompletedAugust 1, 2019
May 1, 2018
1.5 years
February 2, 2010
May 25, 2018
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Adverse Events
basal (day 1 ) and security call (day 75)
Study Arms (2)
A
ACTIVE COMPARATORIOP Dorzolamide-Timolol-Brimonidine group
B
ACTIVE COMPARATORIOP dorzolamide-timolol group
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Clinically relevant ophthalmic or systemic conditions may be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
Montemorelos, Nuevo León, 67500, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- PhD. Ricardo Llamas
- Organization
- Laboratorios Sophia
Study Officials
- STUDY DIRECTOR
Leopoldo M Baiza-Duran, MD
Clinical Research Department. Laboratorios Sophia S.A de C.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 4, 2010
Study Start
February 1, 2006
Primary Completion
August 1, 2007
Study Completion
June 1, 2008
Last Updated
August 1, 2019
Results First Posted
August 1, 2019
Record last verified: 2018-05