At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 166 enrolled
Drug / intervention
DE-111 ophthalmic solution +2 moredrug
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.
A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -
In Brief
A Phase 3 clinical trial evaluating DE-111 ophthalmic solution, Timolol ophthalmic solution 0.5%, and 1 other intervention for Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 166 participants across 1 site.
Detailed Summary
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Angle Glaucoma, Ocular Hypertension
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedApr 26, 2011
Enrollment StartMay 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.2 years ago
Interventions
DE-111 ophthalmic solutiondrug
Timolol ophthalmic solution 0.5%drug
Placebo ophthalmic solutiondrug