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New eye drops aim to repair cornea damage in rare vision disorder

NCT ID NCT06452316

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This early-stage trial is testing an experimental eye drop called CSB-001 in 75 people with limbal stem cell deficiency, a condition where the eye's surface can't heal properly, leading to pain and vision loss. The study will check if the drops are safe and if they help improve signs of the disease. Participants will receive the drops in two separate dosing periods with a break in between, followed by a period of observation only.

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 modified human growth factor protein)
What this could lead to
If successful, this could point toward a new treatment option for limbal stem cell deficiency, a condition that can cause vision loss.
What could go wrong
This is a very early Phase 1 trial with only 75 people, focused mainly on safety. It is too soon to know if the drug works, and many early-stage treatments do not pan out.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and/or cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT. * If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD. * Sponsor written confirmation of qualifying LSCD diagnosis. * Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation. Exclusion Criteria: * Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye. * Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete/stable. * Planned ocular surgery on or before Week 20 visit. * Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator. Note: Other inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

limbal stem cell deficiency

As listed by the trial registrant

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

Limbal stem cell deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Francis Price Jr, MD

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Legacy Devers Eye Institute

    RECRUITING

    Portland, Oregon, 97210, United States

  • Loma Linda University Eye Institute

    RECRUITING

    Loma Linda, California, 92354, United States

  • Midwest Cornea Associates, LLC

    RECRUITING

    Carmel, Indiana, 46290, United States

  • Minnesota Eye Consultants

    RECRUITING

    Minnetonka, Minnesota, 55305, United States

  • Stuart A. Terry, MD PA

    RECRUITING

    San Antonio, Texas, 78212, United States

More trials for these conditions

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