CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 489 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.

Search/NCT01342081
NCT01342081Phase 3Completed

A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension -Phase 3, Confirmatory Study-

Santen Pharmaceutical Co., Ltd.·interventional·Posted Apr 26, 2011·Updated Jun 15, 2015

In Brief

A Phase 3 clinical trial evaluating DE-111 ophthalmic solution, Tafluprost ophthalmic solution 0.0015%, and 1 other intervention for Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 489 participants across 1 site.

Detailed Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, 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--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
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

Tafluprost ophthalmic solution 0.0015%drug

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%drug