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

NCT06257355 — Phase 1, Recruiting, 20 participants, Claris Biotherapeutics, Inc.

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

RegistryNCT06257355
StatusRecruiting
PhasePhase 1
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment20 (Estimated)
SponsorClaris Biotherapeutics, Inc. (Industry)
ConditionsCorneal Scar
InterventionsCSB-001 Ophthalmic Solution 0.1% (Biological)
Datesstart 2024-02-05, primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2024-02-13, last updated 2026-04-07
Locations7 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Corneal Scar All trials of CSB-001 Ophthalmic Solution 0.1%

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
CSB-001 QIDExperimentalBiological: CSB-001 Ophthalmic Solution 0.1%One drop CSB-001 four times daily for 14 days in the study eye
CSB-001 TIDExperimentalBiological: CSB-001 Ophthalmic Solution 0.1%One drop CSB-001 three times daily for 14 days in the study eye
  • CSB-001 Ophthalmic Solution 0.1% (Biological): CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

+Outcome measures

Primary outcomes

  • Safety as Assessed by Adverse Event Reporting [Day 1 through Day 56]: Incidence of ocular and systemic adverse events
  • Safety as Assessed by Slit-lamp Biomicroscopy [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
  • Safety as Assessed by Best-Corrected Distance Visual Acuity [Screening through Day 56]: Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart

Secondary outcomes

  • Efficacy as Assessed by Area of Corneal Scar [Screening through Day 56]: Area of corneal scar as measured by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging
  • Efficacy as Assessed by Maximum Depth of Cornea Scar [Screening through Day 56]: Depth measured with AS-OCT imaging
  • Efficacy as Assessed by Volume of Scar [Screening through Day 56]: Volume measured with AS-OCT imaging
  • Efficacy as Assessed by Density of Scar [Screening through Day 56]: Density based on AS-OCT and Pentacam imaging
  • Efficacy as Assessed by Contrast Sensitivity [Screening through Day 56]: Contrast sensitivity measured using Pelli-Robson chart
  • Efficacy as Assessed by Distance Visual Acuity [Screening through Day 56]: Visual acuity measured using the EDTRS visual acuity chart

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (7)

FacilityCityCountryStatus
Loma Linda University Eye InstituteLoma Linda, CaliforniaUnited StatesRecruiting
Midwest Cornea Associates, LLCCarmel, IndianaUnited StatesRecruiting
Francis Price Jr, MDIndianapolis, IndianaUnited StatesRecruiting
Minnesota Eye ConsultantsMinnetonka, MinnesotaUnited StatesRecruiting
Legacy Devers Eye InstitutePortland, OregonUnited StatesRecruiting
Stuart A. Terry, MD PASan Antonio, TexasUnited StatesRecruiting
Virginia Eye ConsultantsNorfolk, VirginiaUnited StatesRecruiting