This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
131
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Matching vehicle control without the drug substance
Eye Care North
Cave Creek, Arizona, United States
Loma Linda University Eye Institute
Loma Linda, California, United States
Nvision Clinical Research, LLC
Los Angeles, California, United States
Global Research Foundation
Los Angeles, California, United States
UCLA Stein Eye Institute
Los Angeles, California, United States
Efficacy as Assessed by Complete Corneal Healing
Proportion of subjects achieving complete corneal healing as assessed by the Central Reading Center
Time frame: Week 8 through Week 10
Safety as Assessed by Adverse Event Reporting
Incidence of ocular and systemic adverse events
Time frame: Screening through Week 10
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 Week 10
Safety as Assessed by Intraocular Pressure
Change in baseline in intraocular pressure using the Goldmann tonometry
Time frame: Screening through Week 10
Safety as Assessed by Dilated Fundus Examination
Change from baseline in observed anomalies of the peripheral retina, macula, choroid, optic nerve and vitreous (cup/disc ratio)
Time frame: Screening through Week 10
Safety as Assessed by Best-Corrected Distance Visual Acuity
Change from baseline using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart
Time frame: Screening through Week 10
Efficacy as Assessed by Corneal Healing
Time to corneal healing based on assessments by the Central Reading Center
Time frame: Week 1 through Week 10
Efficacy as Assessed by Corneal Healing at Week 4
Proportion of subjects achieving corneal healing at Week 4 assessed by the Central Reading Center
Time frame: Week 1 through Week 4
Efficacy as Assessed by Corneal Healing at Week 4 and Week 8 Sustained for Two Weeks
Proportion of subjects achieving corneal healing at Week 4 and Week sustained for 2 weeks as assessed by the investigator
Time frame: Weeks 4 and 8 through Week 10
Efficacy as Assessed by Decrease in Lesion Size
Time to ≥20% decrease in lesion size (maximum diameter) from baseline assessed by the Central Reading Center
Time frame: Week 1 through Week 10
Efficacy as Assessed by Time to Corneal Healing
Time to corneal healing based on assessments by the investigator
Time frame: Week 1 through Week 10
Efficacy as Assessed by Best Corrected Distance Visual Acuity
Proportion of subjects achieving a ≥15-letter gain in the study eye from baseline in Best Corrected Distance Visual Acuity
Time frame: Week 1 through Weeks 4 and 8
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