Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Information source: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Open Angle Glaucoma; Ocular Hypertension
Intervention: dorzolamide-timolol-brimonidine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Laboratorios Sophia S.A de C.V. Official(s) and/or principal investigator(s):
Leopoldo M Baiza-Duran, MD, Study Director, Affiliation: Clinical Research Department. Laboratorios Sophia S.A de C.V.
Summary
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To characterize the intraocular pressure throughout the study period. To evaluate the reduction of intraocular pressure in both groups of treatment.
Secondary outcome: To follow and compare the safety parameters throughout the study period in both groups of 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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.
Locations and Contacts
Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos, Montemorelos, Nuevo Leon 67500, Mexico
Additional Information
Starting date: February 2006
Last updated: February 3, 2010
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