NCT06257355 Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
| NCT ID | NCT06257355 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Claris Biotherapeutics, Inc. |
| Condition | Corneal Scar |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-02-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision. * Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit. * Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer. * Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea. * Subjects must have the ability and willingness to comply with study procedures. Exclusion Criteria: * Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit. * Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images. * No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images. * Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active. * Ocular surgery planned during the study treatment period. * Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct. Note: Other inclusion/exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06257355 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Corneal Scar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06257355 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06257355 currently recruiting?
Yes, NCT06257355 is actively recruiting participants. Contact the research team at clinicaltrials@clarisbio.com for enrollment information.
Where is the NCT06257355 trial being conducted?
This trial is being conducted at Loma Linda, United States, Carmel, United States, Indianapolis, United States, Minnetonka, United States and 3 additional locations.
Who is sponsoring the NCT06257355 clinical trial?
NCT06257355 is sponsored by Claris Biotherapeutics, Inc.. The trial plans to enroll 20 participants.