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NCT Number: NCT06257355

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Loma Linda University Eye Institute, Loma Linda, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSB-001 Ophthalmic Solution 0.1%

Biological

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

Primary outcomes

  1. Safety as Assessed by Adverse Event Reporting

    Time frame: Day 1 through Day 56

    Incidence of ocular and systemic adverse events

  2. Safety as Assessed by Slit-lamp Biomicroscopy

    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

  3. Safety as Assessed by Best-Corrected Distance Visual Acuity

    Time frame: Screening through Day 56

    Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart

Secondary outcomes

  1. Efficacy as Assessed by Area of Corneal Scar

    Time frame: Screening through Day 56

    Area of corneal scar as measured by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging

  2. Efficacy as Assessed by Maximum Depth of Cornea Scar

    Time frame: Screening through Day 56

    Depth measured with AS-OCT imaging

  3. Efficacy as Assessed by Volume of Scar

    Time frame: Screening through Day 56

    Volume measured with AS-OCT imaging

  4. Efficacy as Assessed by Density of Scar

    Time frame: Screening through Day 56

    Density based on AS-OCT and Pentacam imaging

  5. Efficacy as Assessed by Contrast Sensitivity

    Time frame: Screening through Day 56

    Contrast sensitivity measured using Pelli-Robson chart

  6. Efficacy as Assessed by Distance Visual Acuity

    Time frame: Screening through Day 56

    Visual acuity measured using the EDTRS visual acuity chart

Study contacts

Contact information is provided by the study sponsor or research team.

Central Operations Representative

CONTACT

[email protected]

949-354-1299

Sponsors and collaborators

Lead sponsor

Claris Biotherapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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