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NCT05376176 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study, sponsored by Santen.

Completed
Registry status
Phase 2
Development phase
86
Enrollment target

NCT05376176 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 86 participants.

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The verdict

NCT05376176, a Phase 2 study, has completed, sponsored by Santen.

COMPLETED
Registry status
Phase 2
Development phase
86 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG STN1010904 ophthalmic suspension 0.03% BID
  • DRUG STN1010904 ophthalmic suspension 0.1% BID
  • DRUG Placebo (Vehicle) BID

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2022-05-19
Est. Completion 2025-05-26
Phase Phase 2

Sponsor

Santen

32 total trials

What the Registry Record Tells You About NCT05376176

The ClinicalTrials.gov registry entry for NCT05376176 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santen, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which STN1010904 ophthalmic suspension 0.03% BID is the first listed.

NCT05376176 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05376176 about?

NCT05376176 is a clinical study titled "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)". 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-...

What is the current status of trial NCT05376176?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2022-05-19. Estimated completion is 2025-05-26.

What interventions are being tested in trial NCT05376176?

The interventions under investigation include: STN1010904 ophthalmic suspension 0.03% BID (DRUG), STN1010904 ophthalmic suspension 0.1% BID (DRUG), Placebo (Vehicle) BID (DRUG).

Who is sponsoring clinical trial NCT05376176?

This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.