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
Percentage of subjects achieving complete corneal healing in study eye as assessed by the Central Reading Center (CRC). Complete corneal healing was defined as absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 8 and the absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 10.
Time frame: Week 8 through Week 10
Safety as Assessed by Adverse Event Reporting
Number of participants with ocular and systemic adverse events
Time frame: Screening (Day 0) through Week 10
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LoBue Laser and Eye Medical Center, Inc.
Murrieta, California, United States
California Eye Specialists Medical Group Inc.
Pasadena, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Gordon Schanzlin New Vision Institute
San Diego, California, United States
Atlantis Eyecare
Torrance, California, United States
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