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NCT04276558 · ClinicalTrials.gov registry record · Phase 2
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
A Phase 2 study, sponsored by Recordati Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT04276558: Completed Phase 2 study, sponsored by Recordati Group.
NCT04276558 is a Phase 2 study that has completed, run by Recordati Group. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04276558, a Phase 2 study, has completed, sponsored by Recordati Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study Summary
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.
Primary Outcome
The primary endpoint of this study is the percentage of patients achieving complete corneal healing of PED or corneal ulcer at Week 8, defined as no corneal fluorescein staining in the area of the PED or corneal ulcer as assessed by an independent central reading centre.
Interventions
- OTHER Vehicle
- DRUG Udonitrectag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2020-10-13 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 2 |
What the finished NCT04276558 record still lists
NCT04276558 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT04276558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04276558 about?
NCT04276558 is a clinical study titled "REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients". A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.
What is the current status of trial NCT04276558?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2020-10-13. Estimated completion is 2024-04-29.
What interventions are being tested in trial NCT04276558?
The interventions under investigation include: Vehicle (OTHER), Udonitrectag (DRUG).
Who is sponsoring clinical trial NCT04276558?
This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04276558's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 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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