Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

May 12, 2026 updated by: Claris Biotherapeutics, Inc.

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1K1
        • Dr. Gregory Moloney
    • Ontario
      • Ottawa, Ontario, Canada, K1G 5L1
        • Precision Cornea Centre
      • Toronto, Ontario, Canada, M5T 3A9
        • Kensington Eye Institute
  • United States
    • Arizona
      • Cave Creek, Arizona, United States, 85331
        • Eye Care North
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Eye Institute
      • Los Angeles, California, United States, 90041
        • Global Research Foundation
      • Los Angeles, California, United States, 90095
        • UCLA Stein Eye Institute
      • Los Angeles, California, United States, 90013
        • NVision Clinical Research, LLC
      • Murrieta, California, United States, 92562
        • LoBue Laser and Eye Medical Center, Inc.
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group Inc.
      • Rancho Cordova, California, United States, 95670
        • Martel Eye Medical Group
      • San Diego, California, United States, 92122
        • Gordon Schanzlin New Vision Institute
      • Torrance, California, United States, 90505
        • Atlantis Eyecare
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Dept. of Ophthalmology
      • Colorado Springs, Colorado, United States, 80907
        • Vision Institute
      • Littleton, Colorado, United States, 80120
        • Corneal Consultants of Colorado
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Advanced Research
      • Jacksonville, Florida, United States, 32256
        • Bowden Eye and Associates
      • Ormond Beach, Florida, United States, 32174
        • International Eye Associates, PA
      • Palm Beach, Florida, United States, 33418
        • Bascom Palmer Eye Institute at Palm Beach Gardens
      • Tampa, Florida, United States, 33603
        • International Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Eye Consultants of Atlanta
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Midwest Cornea Associates, LLC
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute
      • Lexington, Kentucky, United States, 40517
        • Kentucky Eye Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Minnesota
      • Edina, Minnesota, United States, 55436
        • Cornea and Contact Lens Institute of Minnesota
      • Minnetonka, Minnesota, United States, 55305
        • Minnesota Eye Consultants
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
      • St Louis, Missouri, United States, 63131
        • Ophthalmology Associates
    • New Jersey
      • Palisades Park, New Jersey, United States, 07650
        • Metropolitan Eye Research and Surgery Institute
    • New York
      • Babylon, New York, United States, 11702
        • SightMD
      • Slingerlands, New York, United States, 12159
        • Cornea Consultants of Albany
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Eye Center
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Eye Consultants of North Dakota
    • Ohio
      • Columbus, Ohio, United States, 43212
        • The Ohio State University, Department of Ophthalmology and Visual Sciences
    • Oregon
      • Portland, Oregon, United States, 97210
        • Devers Eye Institute
    • Pennsylvania
      • Hazle Township, Pennsylvania, United States, 18202
        • Hazleton Eye Specialists
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Eye Center
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Carolina Cataract & Laser Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • BLINK Research Center, LLC
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin; The Mitchel and Shannon Wong Eye Institute
      • San Antonio, Texas, United States, 78212
        • Stuart A. Terry, MD PA
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK). Subjects with bilateral NK may enroll in the study but only one eye will be selected as the study eye (worse eye) and be treated with test article.
  • Subjects with no clinical evidence of improvement in the PED or corneal ulcer within the 2 weeks prior to study enrollment despite the use of conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops and medications that can decrease corneal sensitivity; therapeutic contact lenses [either silicone hydrogel or rigid gas permeable]) as determined by the investigator or referring physician's medical record.
  • Subjects with clinical evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant in the study eye in the opinion of the investigator assessed with a cotton wisp.
  • Pinhole distance visual acuity score ≤ 75 ETDRS letters measured with a LogMAR chart (≥ 0.2 LogMAR, ≤ 20/32 Snellen or worse Snellen or ≤ 0.625 decimal fraction) in the study eye.
  • Subjects must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

  • Any active ocular infection (bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in either eye in the opinion of the investigator. Infectious epithelial keratitis including herpetic keratitis (i.e., dendritic lesions or geographic ulcers) in either eye is excluded. Subjects on oral antibiotic at the time of screening are eligible but should continue the medication for the duration of the study.
  • Previous use of Oxervate in the study eye with last administration within the past 2 months.
  • Any other ocular disease, except glaucoma, that will require topical ocular treatment in the study eye over the course of the study.
  • Use of any other topical treatments other than the study medication provided by the Sponsor and allowed by the study protocol can be administered to the study eye over the course of the study. The following are exceptions: a) Allowance for use of preservative-free antibiotic eye drops if prescribed by the investigator and b) Allowance for use of a non-preserved IOP-lowering prostaglandin topical ocular drop administered once-daily (QD) in glaucomatous eyes over the course of the study.

Note: Other inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CSB-001 Investigational Treatment Arm
One drop CSB-001 four times daily for 8 weeks in the study eye
Biological: CSB-001 Ophthalmic Solution 0.1%
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Placebo Comparator: Vehicle Control Arm
One drop matching vehicle four times daily for 8 weeks in the study eye
Biological: Vehicle Control
Matching vehicle control without the drug substance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy as Assessed by Complete Corneal Healing
Time Frame: Week 8 through Week 10
Percentage of subjects achieving complete corneal healing in study eye as assessed by the Central Reading Center (CRC). Complete corneal healing was defined as absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 8 and the absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 10.
Week 8 through Week 10
Safety as Assessed by Adverse Event Reporting
Time Frame: Screening (Day 0) through Week 10
Number of participants with ocular and systemic adverse events
Screening (Day 0) through Week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy as Assessed by Corneal Healing
Time Frame: Week 1 through Week 10
Time to corneal healing based on assessments by the Central Reading Center
Week 1 through Week 10
Efficacy as Assessed by Corneal Healing at Week 4
Time Frame: Week 1 through Week 4
Proportion of subjects achieving corneal healing at Week 4 assessed by the Central Reading Center
Week 1 through Week 4
Efficacy as Assessed by Corneal Healing at Week 4 and Week 8 Sustained for Two Weeks
Time Frame: Weeks 4 and 8 through Week 10
Proportion of subjects achieving corneal healing at Week 4 and Week sustained for 2 weeks as assessed by the investigator
Weeks 4 and 8 through Week 10
Efficacy as Assessed by Decrease in Lesion Size
Time Frame: Week 1 through Week 10
Time to ≥20% decrease in lesion size (maximum diameter) from baseline assessed by the Central Reading Center
Week 1 through Week 10
Efficacy as Assessed by Time to Corneal Healing
Time Frame: Week 1 through Week 10
Time to corneal healing based on assessments by the investigator
Week 1 through Week 10
Efficacy as Assessed by Best Corrected Distance Visual Acuity
Time Frame: Week 1 through Weeks 4 and 8
Proportion of subjects achieving a ≥15-letter gain in the study eye from baseline in Best Corrected Distance Visual Acuity
Week 1 through Weeks 4 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Claris Biotherapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSB-C20-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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