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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 is a Phase 1 study that has completed, run by Claris Biotherapeutics. The registered enrollment target is 131 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04909450
The ClinicalTrials.gov registry entry for NCT04909450 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Claris Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CSB-001 Ophthalmic Solution 0.1% is the first listed.
NCT04909450 reports 0 study locations.
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.
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