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NCT06257355
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
Phase 1 trial testing CSB-001 Ophthalmic Solution 0.1% in Corneal Scar in 20 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Claris Biotherapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 5 February 2024 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- CSB-001 Ophthalmic Solution 0.1% — full drug profile →
Conditions studied
- Corneal Scar — all drugs for Corneal Scar →
Sponsor
Claris Biotherapeutics, Inc. — full company profile →
Who can join
Adults 18 to 80, any sex, with Corneal Scar. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Regenerative Therapy for Corneal Scarring Disorders.
Chandran C, Santra M, Rubin E, Geary ML, et al · · 2024 · cited 17× · PMID 38540264 · DOI 10.3390/biomedicines12030649
Verify or expand the search:
- PubMed search for NCT06257355
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CSB-001 Ophthalmic Solution 0.1%
Trials testing the same drug.
- NCT06452316 — Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficien · Phase 1 · recruiting
- NCT04909450 — Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects · Phase 1, PHASE2 · completed
Other Claris Biotherapeutics, Inc. trials
Trials by the same sponsor.
- NCT06452316 — Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficien · Phase 1 · recruiting
- NCT04909450 — Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06257355 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Claris Biotherapeutics, Inc.
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06257355.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing