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NCT02822742

A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study

Completed Phase 3 Last updated 20 November 2017
What this trial tests

Phase 3 trial testing DE-117 ophthalmic solution in Primary Open Angle Glaucoma or Ocular Hypertension in 26 participants. Completed in 28 April 2017.

Timeline
2 July 2016
Primary endpoint
28 April 2017
28 April 2017

Quick facts

Lead sponsorSanten Pharmaceutical Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment26
Start date2 July 2016
Primary completion28 April 2017
Estimated completion28 April 2017
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Santen Pharmaceutical Co., Ltd. — full company profile →

Who can join

20 and older, any sex, with Primary Open Angle Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study.
    Aihara M, Ropo A, Lu F, Kawata H, et al · · 2020 · cited 40× · PMID 32572719 · DOI 10.1007/s10384-020-00748-x
  2. Efficacy and Patient Tolerability of Omidenepag Isopropyl in the Treatment of Glaucoma and Ocular Hypertension.
    Matsuo M, Matsuoka Y, Tanito M. · · 2022 · cited 23× · PMID 35510270 · DOI 10.2147/opth.s340386
  3. Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients.
    Sharif NA. · · 2023 · cited 5× · PMID 37375739 · DOI 10.3390/ph16060791

Verify or expand the search:

Other trials of DE-117 ophthalmic solution

Trials testing the same drug.

Other recruiting trials for Primary Open Angle Glaucoma or Ocular Hypertension

Currently open trials in the same condition.

Other Santen Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02822742.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing