Study to Evaluate the Safety and Efficacy of CSB-001 Opht... | NCT06257355

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CSB-001 QID	Experimental	One drop CSB-001 four times daily for 14 days in the study eye	Biological: CSB-001 Ophthalmic Solution 0.1%
CSB-001 TID	Experimental	One drop CSB-001 three times daily for 14 days in the study eye	Biological: CSB-001 Ophthalmic Solution 0.1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CSB-001 Ophthalmic Solution 0.1%	Biological	CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	CSB-001 QID CSB-001 TID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as Assessed by Adverse Event Reporting	Incidence of ocular and systemic adverse events	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	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	Screening through Day 56

Secondary Outcomes

Measure	Description	Time Frame
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	Screening through Day 56
Efficacy as Assessed by Maximum Depth of Cornea Scar

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Subjects must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

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.
Ocular surgery planned during the study treatment period.
Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.

Note: Other inclusion/exclusion criteria apply.