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New eye drops aim to heal corneal damage in rare disease

NCT ID NCT05555589

Disease control Sponsor: ReGenTree, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 3 study tests whether RGN-259 eye drops can heal persistent corneal defects in people with neurotrophic keratopathy, a condition where the cornea loses sensation and doesn't heal properly. About 70 adults will use the drops five times daily for 28 days or a placebo. The main goal is to see if the defect fully heals by day 29.

What this could mean

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

Active substance
RGN-259 (Thymosin Beta 4) eye drops
What this could lead to
If successful, this could provide a new treatment option for neurotrophic keratopathy, helping heal persistent corneal defects and potentially preventing vision loss.
What could go wrong
This is a Phase 3 trial, but with only 70 participants, results may not apply to everyone. The treatment may not work better than placebo, and eye drops can cause irritation or infection.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

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

Started

Apr 2023

Expected to finish

May 2026

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 1. Be male or female of any race, at least 18 years of age; 2. Have provided written informed consent; 3. Be able and willing to follow instructions, including participation in all study assessments and visits; 4. At the time of Visit 1, have documentation or observation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal epithelial defect that has not resolved after 1 week of conventional treatment using non-preserved ocular lubricants, non-preserved topical ophthalmic antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, and/or therapeutic contact lenses; 5. Have stage 2 or 3 neurotrophic keratopathy (Mackie Classification) in at least one eye of which the longest dimension (length or width) of the defect measures a minimum length of 1 mm (study eye) and which is confirmed by the Investigator not to be simply superficial punctate keratitis, at Visit 1; 6. Have evidence of decreased corneal sensitivity ≤40 mm using the Cochet-Bonnet aesthesiometer at Visit 1; 7. Have BCVA score ≤75 letter counts in the study eye based on the ETDRS protocol; 8. Have at least one eye (the same eye) satisfy all criteria for d, e, f, g above; 9. Female subjects of child-bearing potential must be non-lactating and using and agree to continue using an acceptable method of contraception for at least 4 weeks prior to the first dose of study product and until 12 weeks after last dose, and have a negative urine pregnancy test during screening; 10. Male subjects must agree to use an adequate method of contraception. Exclusion Criteria 1. Have any condition that, in the opinion of the Investigator, would interfere with the subject's ability to complete the study, would interfere with the interpretation of safety or efficacy, or would present an undue risk to the subject. 2. Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters; 3. Clinically significant active blepharitis, meibomian gland dysfunction (MGD), or lid margin inflammation, or active ocular allergy in study eye that requires treatment that in the opinion of the investigator may interfere with the study parameters; 4. Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1; 5. Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the Investigator, is the primary cause of the persistent epithelial defect; 6. Have an ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g., follicular conjunctivitis) in the study eye. 7. History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrollment. 8. Prior surgical procedure(s) for the treatment of NK (e.g., tarsorrhaphy, conjunctival flap, etc.) within the three months before study enrollment with the exception of amniotic membrane transplantation. 9. Have any planned ocular surgical procedures or are likely to require ocular surgery for the study eye during the study; 10. Have received Botox® injection to induce blepharoptosis in the study eye within 90 days prior to Visit 1; 11. Have used contact lenses (for therapeutic or refractive correction) in the study eye within 14 days prior to Visit 1, or anticipate use of contact lenses during the study period. 12. Have used OxervateTM in the study eye within the past 2 months; 13. Anticipate use of serum tears in the study eye during the study period. 14. Have a presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct; 15. Have used drugs which affect lacrimation or function of the trigeminal nerve within 30 days of Visit 1 or anticipate use of these systemic medication throughout the course of the study; 16. Have any autoimmune or chronic inflammatory disease that might have hindered the efficacy of the study treatment or its evaluation; 17. Be on topical (Ocular/Nasal) immunosuppressive therapy within 30 days prior to screening or is likely to require this during the course of the study; 18. Have a known allergy and/or sensitivity to the study product or its components; 19. History of drug, medication or alcohol abuse or addiction; 20. Have participated in an investigational drug study within 30 days prior to screening; 21. Have fever, inflammation, or systemic signs of illness suggestive of systemic or invasive infection, including COVID-19 or a positive test for COVID-19, within 2 weeks prior to first dose of study drug.

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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 keratopathy

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

    31 sites in 4 countries. 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

  • Advance Vision Research Institute

    RECRUITING

    Longmont, Colorado, 80503, United States

  • Aiken Prevención & Cirugía Ocular

    RECRUITING

    Valencia, Valencia, 46004, Spain

  • Azienda Ospedaliero Universitaria Careggi

    RECRUITING

    Florence, Firenze, 50134, Italy

  • Berkeley Eye Center

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • CORE, Inc. / Vita Eye Clinic

    ACTIVE_NOT_RECRUITING

    Shelby, North Carolina, 28150, United States

  • Cataract & Laser Institute of Southern Oregon

    RECRUITING

    Medford, Oregon, 97504, United States

  • Cleveland Clinic, Cole Eye Institute

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons

    RECRUITING

    Danbury, Connecticut, 06810, United States

  • Duke Eye Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Gabinet Okulistyczny Prof Edward Wylegala

    RECRUITING

    Katowice, Silesian Voivodeship, 40-594, Poland

  • Harvard Eye Associates

    RECRUITING

    Laguna Hills, California, 92653, United States

  • Hospital La Arruzafa

    RECRUITING

    Córdoba, Córdoba, 14012, Spain

  • Huffman & Huffman, PSC

    ACTIVE_NOT_RECRUITING

    Lexington, Kentucky, 40509, United States

  • IMO Barcelona, Grupo Miranza

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Instituto Oftalmológico Fernández-Vega

    RECRUITING

    Oviedo, Principality of Asturias, 33012, Spain

  • Loma Linda University Eye Institute

    RECRUITING

    Loma Linda, California, 92354, United States

  • MCOA Eye Care

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Metropolitan Eye Research and Surgery Institute

    RECRUITING

    Palisades Park, New Jersey, 07650, United States

  • Midwest Cornea Associates, LLC.

    RECRUITING

    Carmel, Indiana, 46290, United States

  • Midwest Vision Research Foundation

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nature Coast Clinical Research

    RECRUITING

    Crystal River, Florida, 34429, United States

  • Northwestern

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OHSU Casey Eye Institute

    RECRUITING

    Portland, Oregon, 97239, United States

  • Oculus Research

    ACTIVE_NOT_RECRUITING

    Raleigh, North Carolina, 27617, United States

  • Pacific ClearVision Institute

    ACTIVE_NOT_RECRUITING

    Eugene, Oregon, 97401, United States

  • Retina Consultants of Southern Colorado

    ACTIVE_NOT_RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • Thomas Eye Group, P.C.

    RECRUITING

    Sandy Springs, Georgia, 30328, United States

  • UPMC Eye Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Miami - Bascom Palmer Eye Institute, Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of South Florida, Ophthalmolgoy

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Washington, Department of Ophthalmology

    RECRUITING

    Seatle, Washington, 98104, United States

  • Università di Brescia

    RECRUITING

    Brescia, Brescia, 25123, Italy

  • Virginia Eye Consultants

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Washington University Eye Center

    RECRUITING

    St Louis, Missouri, 63108, United States

More trials for these conditions

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