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New eye drops offer hope for rare eye condition

NCT ID NCT07422389

Disease control Sponsor: BRIM Biotechnology 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program provides access to BRM421 eye drops for adults with mild to moderate limbal stem cell deficiency (LSCD), a condition that can cause vision problems. Participants use the drops twice daily for at least 12 weeks and have monthly checkups. The goal is to see if this treatment can help manage the disease.

What this could mean

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

Active substance
BRM421 ophthalmic solution (eye drops)
What this could lead to
If successful, this could provide a new treatment option to manage limbal stem cell deficiency, potentially reducing symptoms and improving eye surface health.
What could go wrong
This is an intermediate-size patient access program, not a controlled trial, so results may be less reliable. The treatment may not work for everyone, and long-term safety is still being studied.

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.

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

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: * Adult patients with mild to moderate LSCD who unsatisfied with the standard of care treatments and who seek the treatment with BRM421 Ophthalmic Solution. Patients scheduled for LSC transplant may be included, but treatment with BRM421 should begin only after the surgery. * Be able to sign the informed consent and follow with investigator instructions. * If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives, mechanical spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner) and have a negative urine pregnancy test at the time of consent. Exclusion Criteria: * The patients eligible for the BRIM clinical trial(s). * The patients diagnosed with primary LSCD which is the genetic mutations that lead to LSC dysfunction or destruction. * Have a condition or a situation in which the investigator feels the patients is not suitable and may put the patient at significant risk. * Be a female who is pregnant, nursing, or planning a pregnancy at the time of consent. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives; mechanical spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. The risks of BRM421 among pregnant patients are not known.

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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 (LSCD)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Scheie Eye Institute

    AVAILABLE

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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