Title
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
Phase
Phase 2Lead Sponsor
Laboratorios Sophia S.A de C.V.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Primary Open Angle Glaucoma Ocular HypertensionIntervention/Treatment
brimonidine dorzolamide timolol ...Study Participants
124To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
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.
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.
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.
| Event Type | Organ System | Event Term | A (Triple Therapy) | B (Doble Therapy) |
|---|
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event.
