CSB-001 Ophthalmic Solution 0.1%
BiologicalCSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
NCT Number: NCT06257355
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1
Loma Linda University Eye Institute, Loma Linda, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other inclusion/exclusion criteria apply.
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Time frame: Day 1 through Day 56
Incidence of ocular and systemic adverse events
Time frame: Screening through Day 56
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
Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart
Time frame: Screening through Day 56
Area of corneal scar as measured by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging
Time frame: Screening through Day 56
Depth measured with AS-OCT imaging
Time frame: Screening through Day 56
Volume measured with AS-OCT imaging
Time frame: Screening through Day 56
Density based on AS-OCT and Pentacam imaging
Time frame: Screening through Day 56
Contrast sensitivity measured using Pelli-Robson chart
Time frame: Screening through Day 56
Visual acuity measured using the EDTRS visual acuity chart
Contact information is provided by the study sponsor or research team.
Claris Biotherapeutics, Inc.
Industry
A Two-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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