CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
dorzolamide-timolol-brimonidinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01062971
NCT01062971Phase 2Completed
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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

Laboratorios Sophia S.A de C.V.·interventional·Posted Feb 4, 2010·Updated Aug 1, 2019

In Brief

A Phase 2 clinical trial evaluating dorzolamide-timolol-brimonidine for Primary Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 124 participants across 1 site.

Detailed Summary

To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Open Angle Glaucoma, Ocular Hypertension
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2010
Enrollment StartFeb 1, 2006
Primary CompletionAug 1, 2007
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.4 years ago

Interventions

dorzolamide-timolol-brimonidinedrug

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.