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Neurotrophic KeratitisPhase 1/2NCT04909450

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

A Phase 1/2 study testing CSB-001 Ophthalmic Solution 0.1% in people with Neurotrophic Keratitis, run by Claris Biotherapeutics, Inc. at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurotrophic Keratitis
What is being tested?
CSB-001 Ophthalmic Solution 0.1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
48 sitesin 2 countries
Study dates
24 Aug 2021to 4 Jun 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

United States45 sites

  • Eye Consultants of Atlanta

    Atlanta, Georgia, 30339

  • University of Colorado - Dept. of Ophthalmology

    Aurora, Colorado, 80045

  • University of Texas at Austin; The Mitchel and Shannon Wong Eye Institute

    Austin, Texas, 78712

  • SightMD

    Babylon, New York, 11702

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Advanced Research

    Boynton Beach, Florida, 33437

  • Midwest Cornea Associates, LLC

    Carmel, Indiana, 46290

  • Eye Care North

    Cave Creek, Arizona, 85331

  • Vision Institute

    Colorado Springs, Colorado, 80907

  • The Ohio State University, Department of Ophthalmology and Visual Sciences

    Columbus, Ohio, 43212

  • Duke Eye Center

    Durham, North Carolina, 27710

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • Cornea and Contact Lens Institute of Minnesota

    Edina, Minnesota, 55436

  • Eye Consultants of North Dakota

    Fargo, North Dakota, 58104

  • Hazleton Eye Specialists

    Hazle Township, Pennsylvania, 18202

  • Price Vision Group

    Indianapolis, Indiana, 46260

  • Bowden Eye and Associates

    Jacksonville, Florida, 32256

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • Carolina Cataract & Laser Center

    Ladson, South Carolina, 29456

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80120

  • Loma Linda University Eye Institute

    Loma Linda, California, 92354

  • Nvision Clinical Research, LLC

    Los Angeles, California, 90013

  • Global Research Foundation

    Los Angeles, California, 90041

  • UCLA Stein Eye Institute

    Los Angeles, California, 90095

  • BLINK Research Center, LLC

    Memphis, Tennessee, 38119

  • Minnesota Eye Consultants

    Minnetonka, Minnesota, 55305

  • LoBue Laser and Eye Medical Center, Inc.

    Murrieta, California, 92562

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • International Eye Associates, PA

    Ormond Beach, Florida, 32174

  • Metropolitan Eye Research and Surgery Institute

    Palisades Park, New Jersey, 07650

  • Bascom Palmer Eye Institute at Palm Beach Gardens

    Palm Beach, Florida, 33418

  • California Eye Specialists Medical Group Inc.

    Pasadena, California, 91107

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • UPMC Eye Center

    Pittsburgh, Pennsylvania, 15213

  • Devers Eye Institute

    Portland, Oregon, 97210

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Stuart A. Terry, MD PA

    San Antonio, Texas, 78212

  • Gordon Schanzlin New Vision Institute

    San Diego, California, 92122

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

  • Cornea Consultants of Albany

    Slingerlands, New York, 12159

  • Ophthalmology Associates

    St Louis, Missouri, 63131

  • International Research Center

    Tampa, Florida, 33603

  • Atlantis Eyecare

    Torrance, California, 90505

Other trials in United States

Canada3 sites

  • Precision Cornea Centre

    Ottawa, Ontario, K1G 5L1

  • Kensington Eye Institute

    Toronto, Ontario, M5T 3A9

  • Dr. Gregory Moloney

    Vancouver, British Columbia, V5Z 1K1

Other trials in Canada

About this study

Official title: 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.

Being tested
CSB-001 Ophthalmic Solution 0.1%, Vehicle Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSB-001 Ophthalmic Solution 0.1%Biological

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

  • Vehicle ControlBiological

    Matching vehicle control without the drug substance

Study groups in NCT04909450
Study groupRoleWhat they receive
CSB-001 Investigational Treatment ArmExperimentalOne drop CSB-001 four times daily for 8 weeks in the study eye
Receives: Biological: CSB-001 Ophthalmic Solution 0.1%
Vehicle Control ArmPlacebo comparatorOne drop matching vehicle four times daily for 8 weeks in the study eye
Receives: Biological: Vehicle Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy as Assessed by Complete Corneal Healing

    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.

    Measured: Week 8 through Week 10

  2. Safety as Assessed by Adverse Event Reporting

    Number of participants with ocular and systemic adverse events

    Measured: Screening (Day 0) through Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start24 Aug 2021
  3. Primary completion7 May 2024
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04909450
Sponsor's protocol ID
CSB-C20-003
Status last verified
Apr 2026
First submitted
25 May 2021
Last updated
13 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hamrah P, Yavuz Saricay L, Ozmen MC. Cutting Edge: Topical Recombinant Nerve Growth Factor for the Treatment of Neurotrophic Keratopathy-Biologicals as a Novel Therapy for Neurotrophic Keratopathy. Cornea. 2022 Jun 1;41(6):673-679. doi: 10.1097/ICO.0000000000002974. Epub 2022 Feb 2.

    PubMed 35266655

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CSB-001 Ophthalmic Solution 0.1% in people with Neurotrophic Keratitis, run by Claris Biotherapeutics, Inc. at 48 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy as Assessed by Complete Corneal Healing (time frame: Week 8 through Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04909450, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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