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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: Completed Phase 2 study, sponsored by Santen.
NCT05376176 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline s
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 |
What the finished NCT05376176 record still lists
NCT05376176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which STN1010904 ophthalmic suspension 0.03% BID is the first listed.
NCT05376176 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05376176's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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