CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
DE-117 Ophthalmic 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.

Search/NCT03697811
NCT03697811Phase 3Completed

An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Santen Inc.·interventional·Posted Oct 5, 2018·Updated Aug 30, 2023

In Brief

A Phase 3 clinical trial evaluating DE-117 Ophthalmic Solution for Primary Open-angle Glaucoma and Ocular Hypertension. Completed, enrolled 107 participants across 32 sites.

Detailed Summary

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 5, 2018
Enrollment StartSep 27, 2018
Primary CompletionJan 13, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.7 years ago

Interventions

DE-117 Ophthalmic Solutiondrug

Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.