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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 is a Phase 1 study of Corneal Scar that is actively recruiting participants, run by Claris Biotherapeutics. The registered enrollment target is 20 participants. The trial reports 7 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06257355
The ClinicalTrials.gov registry entry for NCT06257355 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 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 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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
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