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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
Phase 3 trial testing DE-117 ophthalmic solution in Primary Open Angle Glaucoma or Ocular Hypertension in 26 participants. Completed in 28 April 2017.
28 April 2017
Quick facts
| Lead sponsor | Santen Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 2 July 2016 |
| Primary completion | 28 April 2017 |
| Estimated completion | 28 April 2017 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- DE-117 ophthalmic solution — full drug profile →
- Latanoprost ophthalmic solution 0.005% — full drug profile →
Conditions studied
- Primary Open Angle Glaucoma or Ocular Hypertension — all drugs for Primary Open Angle Glaucoma or Ocular Hypertension →
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):
-
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 -
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 -
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:
- PubMed search for NCT02822742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DE-117 ophthalmic solution
Trials testing the same drug.
- NCT02822729 — A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timol · Phase 3 · completed
Other recruiting trials for Primary Open Angle Glaucoma or Ocular Hypertension
Currently open trials in the same condition.
- NCT06865144 — Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Po · Phase 4 · recruiting
- NCT07076303 — A Prospective Study on the Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in Achieving >20% Intraocular Press · recruiting
Other Santen Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06911216 — A Pharmacokinetics (PK) Study in Healthy Adults · EARLY_PHASE1 · completed
- NCT06666855 — A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China · Phase 3 · active not recruiting
- NCT05905653 — Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers · Phase 1 · completed
- NCT05495061 — A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension · Phase 3 · completed
- NCT05503901 — A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02822742 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Santen Pharmaceutical Co., Ltd.
- Last refreshed: 20 November 2017
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