Cure My Disease

Don't miss your cure!

 Log in / Sign up

New eye drops show promise for healing corneal damage

NCT ID NCT04909450

Disease control Sponsor: Claris Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental eye drop called CSB-001 in 131 people with neurotrophic keratitis, a rare condition where the cornea loses sensation and can develop ulcers. Participants used the drops four times daily for 8 weeks. The goal was to see if the drops could fully heal the cornea better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CSB-001 ophthalmic solution (a growth factor protein)
What this could lead to
If it works, this could lead to a new treatment that helps heal corneal damage in people with neurotrophic keratitis.
What could go wrong
This is an early-phase trial with only 131 people, so results may not hold up in larger studies. The condition is rare, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

131 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Neurotrophic keratitis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

neurotrophic keratopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurotrophic keratitis

Contacts and locations

Locations

  • Advanced Research

    Boynton Beach, Florida, 33437, United States

  • Atlantis Eyecare

    Torrance, California, 90505, United States

  • BLINK Research Center, LLC

    Memphis, Tennessee, 38119, United States

  • Bascom Palmer Eye Institute at Palm Beach Gardens

    Palm Beach, Florida, 33418, United States

  • Bowden Eye and Associates

    Jacksonville, Florida, 32256, United States

  • California Eye Specialists Medical Group Inc.

    Pasadena, California, 91107, United States

  • Carolina Cataract & Laser Center

    Ladson, South Carolina, 29456, United States

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017, United States

  • Cornea Consultants of Albany

    Slingerlands, New York, 12159, United States

  • Cornea and Contact Lens Institute of Minnesota

    Edina, Minnesota, 55436, United States

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80120, United States

  • Devers Eye Institute

    Portland, Oregon, 97210, United States

  • Dr. Gregory Moloney

    Vancouver, British Columbia, V5Z 1K1, Canada

  • Duke Eye Center

    Durham, North Carolina, 27710, United States

  • Eye Care North

    Cave Creek, Arizona, 85331, United States

  • Eye Consultants of Atlanta

    Atlanta, Georgia, 30339, United States

  • Eye Consultants of North Dakota

    Fargo, North Dakota, 58104, United States

  • Global Research Foundation

    Los Angeles, California, 90041, United States

  • Gordon Schanzlin New Vision Institute

    San Diego, California, 92122, United States

  • Hazleton Eye Specialists

    Hazle Township, Pennsylvania, 18202, United States

  • International Eye Associates, PA

    Ormond Beach, Florida, 32174, United States

  • International Research Center

    Tampa, Florida, 33603, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Kensington Eye Institute

    Toronto, Ontario, M5T 3A9, Canada

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517, United States

  • LoBue Laser and Eye Medical Center, Inc.

    Murrieta, California, 92562, United States

  • Loma Linda University Eye Institute

    Loma Linda, California, 92354, United States

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670, United States

  • Metropolitan Eye Research and Surgery Institute

    Palisades Park, New Jersey, 07650, United States

  • Midwest Cornea Associates, LLC

    Carmel, Indiana, 46290, United States

  • Minnesota Eye Consultants

    Minnetonka, Minnesota, 55305, United States

  • Nvision Clinical Research, LLC

    Los Angeles, California, 90013, United States

  • Ophthalmology Associates

    St Louis, Missouri, 63131, United States

  • Precision Cornea Centre

    Ottawa, Ontario, K1G 5L1, Canada

  • Price Vision Group

    Indianapolis, Indiana, 46260, United States

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104, United States

  • SightMD

    Babylon, New York, 11702, United States

  • Stuart A. Terry, MD PA

    San Antonio, Texas, 78212, United States

  • Tauber Eye Center

    Kansas City, Missouri, 64111, United States

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

    Columbus, Ohio, 43212, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UCLA Stein Eye Institute

    Los Angeles, California, 90095, United States

  • UPMC Eye Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Colorado - Dept. of Ophthalmology

    Aurora, Colorado, 80045, United States

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

    Austin, Texas, 78712, United States

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108, United States

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502, United States

  • Vision Institute

    Colorado Springs, Colorado, 80907, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.