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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2025-05-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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