At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 enrolled
Drug / intervention
Dorzolamide 2 % eye drops solutiondrug
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.
Randomized, Double-Masked, Active Controlled, Crossover Phase III Equivalence Study of Dorzolamide 2% Eye Drops Solution In Subjects With Open Angle Glaucoma Or Ocular Hypertension
In Brief
A Phase 3 clinical trial evaluating Dorzolamide 2 % eye drops solution for Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. For this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Angle Glaucoma, Ocular Hypertension
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedApr 2009
Primary CompletionFeb 2010
TodayJul 2026
First PostedApr 9, 2009
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.2 years ago
Interventions
Dorzolamide 2 % eye drops solutiondrug
1 drop into eye(s) three times a day for the duration of each treatment phase