drugset / Trial / NCT06257355
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-02-05
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CSB-001 | Protein / enzyme biologic | 0.1 % | Other |