Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Corneal Scar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CSB-001 QID

One drop CSB-001 four times daily for 14 days in the study eye

Group Type EXPERIMENTAL

CSB-001 Ophthalmic Solution 0.1%

Intervention Type BIOLOGICAL

CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

CSB-001 TID

One drop CSB-001 three times daily for 14 days in the study eye

Group Type EXPERIMENTAL

CSB-001 Ophthalmic Solution 0.1%

Intervention Type BIOLOGICAL

CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Interventions

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CSB-001 Ophthalmic Solution 0.1%

CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No