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NCT04485546 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
A Phase 4 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT04485546: Completed Phase 4 study, sponsored by Dompé Farmaceutici S.p.A.
NCT04485546 is a Phase 4 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04485546, a Phase 4 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).
Primary Outcome
Percentage of patients who experienced corneal epithelial healing. Corneal epithelial healing was defined by the central reading center as the absence of persistent epithelial staining abnormalities related to disease.
Interventions
- DRUG cenegermin-bkbj
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 4 |
What the finished NCT04485546 record still lists
NCT04485546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which cenegermin-bkbj is the first listed.
NCT04485546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04485546 about?
NCT04485546 is a clinical study titled "Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis". This study is to evaluate the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).
What is the current status of trial NCT04485546?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2020-09-09. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT04485546?
The interventions under investigation include: cenegermin-bkbj (DRUG).
Who is sponsoring clinical trial NCT04485546?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04485546's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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