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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Loma Linda University Eye Institute
Loma Linda, California, United States
RECRUITINGMidwest Cornea Associates, LLC
Carmel, Indiana, United States
RECRUITINGFrancis Price Jr, MD
Indianapolis, Indiana, United States
RECRUITINGMinnesota Eye Consultants
Minnetonka, Minnesota, United States
RECRUITINGLegacy Devers Eye Institute
Portland, Oregon, United States
RECRUITINGStuart A. Terry, MD PA
San Antonio, Texas, United States
RECRUITINGVirginia Eye Consultants
Norfolk, Virginia, United States
RECRUITINGSafety as Assessed by Adverse Event Reporting
Incidence of ocular and systemic adverse events
Time frame: Day 1 through Day 56
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
Time frame: Screening through Day 56
Safety as Assessed by Best-Corrected Distance Visual Acuity
Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart
Time frame: Screening through Day 56
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
Time frame: Screening through Day 56
Efficacy as Assessed by Maximum Depth of Cornea Scar
Depth measured with AS-OCT imaging
Time frame: Screening through Day 56
Efficacy as Assessed by Volume of Scar
Volume measured with AS-OCT imaging
Time frame: Screening through Day 56
Efficacy as Assessed by Density of Scar
Density based on AS-OCT and Pentacam imaging
Time frame: Screening through Day 56
Efficacy as Assessed by Contrast Sensitivity
Contrast sensitivity measured using Pelli-Robson chart
Time frame: Screening through Day 56
Efficacy as Assessed by Distance Visual Acuity
Visual acuity measured using the EDTRS visual acuity chart
Time frame: Screening through Day 56
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