Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Status and phase
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Treatments
Details and patient eligibility
About
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Full 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.
Enrollment
Sex
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
124 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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