Who is sponsoring NCT05376176?

NCT05376176 is sponsored by Santen Inc..

What drugs are being tested in NCT05376176?

Interventions in NCT05376176: STN1010904 ophthalmic suspension 0.03% BID, STN1010904 ophthalmic suspension 0.1% BID, Placebo (Vehicle) BID.

What condition does NCT05376176 study?

NCT05376176 studies Fuchs Endothelial Corneal Dystrophy.

Is NCT05376176 still recruiting?

NCT05376176 is currently completed. Last updated 15 July 2025.

Last reviewed 2025-07-15 · How we verify

NCT05376176: PHANTOM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

Completed Phase 2 Last updated 15 July 2025

What this trial tests

Phase 2 trial testing STN1010904 ophthalmic suspension 0.03% BID in Fuchs Endothelial Corneal Dystrophy in 86 participants. Completed in 26 May 2025.

Timeline

19 May 2022

Primary endpoint
26 May 2025

26 May 2025

Quick facts

Lead sponsor	Santen Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	86
Start date	19 May 2022
Primary completion	26 May 2025
Estimated completion	26 May 2025
Sites	15 locations across France, United States, India

Drugs / interventions tested

STN1010904 ophthalmic suspension 0.03% BID — full drug profile →
STN1010904 ophthalmic suspension 0.1% BID — full drug profile →
Placebo (Vehicle) BID

Conditions studied

Fuchs Endothelial Corneal Dystrophy — all drugs for Fuchs Endothelial Corneal Dystrophy →

Sponsor

Santen Inc. — full company profile →

Who can join

Adults 30 to 75, any sex, with Fuchs Endothelial Corneal Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Therapeutic future of Fuchs endothelial corneal dystrophy: An ongoing way to explore.
Liu JX, Chiang TL, Hung KF, Sun YC. · · 2024 · cited 5× · PMID 38654984 · DOI 10.4103/tjo.tjo-d-23-00115

Verify or expand the search:

Other recruiting trials for Fuchs Endothelial Corneal Dystrophy

Currently open trials in the same condition.

NCT04440280 — Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy · Phase 2 · recruiting

Other Santen Inc. trials

Trials by the same sponsor.

NCT05665387 — Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subject · Phase 2 · completed
NCT04742283 — Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate O · Phase 2 · completed
NCT03858894 — Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primar · Phase 2 · completed
NCT03711929 — LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the T · Phase 3 · terminated
NCT03691662 — A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalm · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05376176 (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 Inc.
Last refreshed: 15 July 2025

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/NCT05376176.

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