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Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
NCT06257355 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06257355 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Indiana, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06257355?
The interventions under investigation include: CSB-001 Ophthalmic Solution 0.1% (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06257355?
This trial is sponsored by Claris Biotherapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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