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.
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.
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.
Parallel
CSB-001 Ophthalmic Solution 0.1%
Biological/VaccineCSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Safety as Assessed by Adverse Event Reporting
Incidence of ocular and systemic adverse events
Safety as Assessed by Slit-lamp Biomicroscopy
Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15
Safety as Assessed by Best-Corrected Distance Visual Acuity
Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart
Efficacy as Assessed by Area of Corneal Scar
Area of corneal scar as measured by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging
Efficacy as Assessed by Maximum Depth of Cornea Scar
Depth measured with AS-OCT imaging
Efficacy as Assessed by Volume of Scar
Volume measured with AS-OCT imaging
Efficacy as Assessed by Density of Scar
Density based on AS-OCT and Pentacam imaging
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