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NCT04909450 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
A Phase 1 study, sponsored by Claris Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 131
- Enrollment target
NCT04909450: Completed Phase 1 study, sponsored by Claris Biotherapeutics.
NCT04909450 is a Phase 1 study that has completed, run by Claris Biotherapeutics. The registered enrollment target is 131 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04909450, a Phase 1 study, has completed, sponsored by Claris Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 131 participants
- Enrollment target
Study Summary
This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.
Primary Outcome
Percentage of subjects achieving complete corneal healing in study eye as assessed by the Central Reading Center (CRC). Complete corneal healing was defined as absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 8 and the absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 10.
Interventions
- BIOLOGICAL CSB-001 Ophthalmic Solution 0.1%
- BIOLOGICAL Vehicle Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 1 |
What the finished NCT04909450 record still lists
NCT04909450 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 2 interventions - of which CSB-001 Ophthalmic Solution 0.1% is the first listed.
NCT04909450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04909450 about?
NCT04909450 is a clinical study titled "Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects". This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). Du...
What is the current status of trial NCT04909450?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2021-08-24. Estimated completion is 2024-06-04.
What interventions are being tested in trial NCT04909450?
The interventions under investigation include: CSB-001 Ophthalmic Solution 0.1% (BIOLOGICAL), Vehicle Control (BIOLOGICAL).
Who is sponsoring clinical trial NCT04909450?
This trial is sponsored by Claris Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04909450's enrollment target sits among peer trials
131 439th of 2000 higher than 1,562 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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