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NCT06257355 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
A Phase 1 study of Corneal Scar, sponsored by Claris Biotherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT06257355: Recruiting Phase 1 study of Corneal Scar, sponsored by Claris Biotherapeutics.
NCT06257355 is a Phase 1 study of Corneal Scar that is actively recruiting participants, run by Claris Biotherapeutics. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06257355, a Phase 1 study of Corneal Scar, is actively recruiting participants, sponsored by Claris Biotherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.
Primary Outcome
Incidence of ocular and systemic adverse events
Conditions Studied
Interventions
- BIOLOGICAL CSB-001 Ophthalmic Solution 0.1%
Study Locations (7)
Indiana
- Midwest Cornea Associates, LLC - Carmel
- Francis Price Jr, MD - Indianapolis
California
- Loma Linda University Eye Institute - Loma Linda
Minnesota
- Minnesota Eye Consultants - Minnetonka
Oregon
- Legacy Devers Eye Institute - Portland
Texas
- Stuart A. Terry, MD PA - San Antonio
Virginia
- Virginia Eye Consultants - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-02-05 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 1 |
What NCT06257355 shows while recruiting
NCT06257355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Corneal Scar appearing as the primary indexed condition, and to 1 intervention - of which CSB-001 Ophthalmic Solution 0.1% is the first listed.
NCT06257355 lists 7 locations in 6 states (Indiana, California, Minnesota).
Frequently Asked Questions
What is clinical trial NCT06257355 about?
NCT06257355 is a clinical study titled "Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars". This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will...
What is the current status of trial NCT06257355?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-02-05. Estimated completion is 2026-01-31.
What conditions does trial NCT06257355 study?
This clinical trial studies the following conditions: Corneal Scar.
What interventions are being tested in trial NCT06257355?
The interventions under investigation include: CSB-001 Ophthalmic Solution 0.1% (BIOLOGICAL).
Who is sponsoring clinical trial NCT06257355?
This trial is sponsored by Claris Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06257355 being conducted?
This trial has 7 study locations across California, Indiana, Minnesota, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06257355's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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