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Can a thymosin beta 4 eye drop soothe dry eye?

NCT ID NCT03937882

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This Phase 3 trial tests whether RGN-259, an eye drop containing thymosin beta 4, can reduce the signs and symptoms of dry eye. About 700 adults with a history of dry eye will use the drops four times a day for two weeks, or a placebo. Researchers will measure changes in corneal staining and eye discomfort to see if the treatment helps.

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 it works, RGN-259 could offer a new treatment option for people with dry eye, potentially reducing discomfort and improving eye surface health.
What could go wrong
This is a Phase 3 trial, but success is not guaranteed. The treatment may not prove more effective than placebo, and eye drops can cause irritation or other side effects.

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

700 people

The number who actually took part.

Started

May 2019

Finished

Oct 2021

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: * Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye prior to Visit 1; * Have a history of use or desire to use eye drops for dry eye symptoms Exclusion Criteria: * Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; * Have used any eye drops within 2 hours of Visit 1; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months; * Have used Restasis®, Xiidra® Cequa®, or TrueTear® within 45 days of Visit 1 or Lipiflow® within 6 months of Visit 1; * Have an intraocular pressure (IOP) \> 25 mmHg at Visit 1; * Have any planned ocular and/or lid surgeries over the study period; * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1; * Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); * Have corrected visual acuity greater than or equal to logarithm of the minimum angle of resolution (logMAR) +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1; * Have an uncontrolled systemic disease; * Be a woman who is pregnant, nursing or planning a pregnancy; * Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy), or is post-menopausal (without menses for 12 consecutive months); * 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; intrauterine device (IUD); or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study; * Have a known allergy and/or sensitivity to the study drug or its components; * Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * Have used an investigational drug or device within 30 days of Visit 1; * Be currently using any medication known to cause ocular drying (e.g., antihistamines, anti-depressants) or increased lacrimation (e.g., cholinergics) that is not used on a stable dosing regimen for at least 30 days prior to Visit 1; * Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids), ophthalmic topical steroids, topical nonsteroidal antiinflammatory drugs (NSAIDs), topical antibiotics, immunotherapy, or cytotoxic therapy within 14 days of Visit 1 or anticipate such therapy throughout the study period. * Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

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

Dry eye Dry eye syndromes

Contacts and locations

Locations

  • Andover Eye Associates

    Andover, Massachusetts, 01810, United States

  • Andover Eye Associates

    Raynham, Massachusetts, 02767, United States

  • Andover Eye Associates

    Warwick, Rhode Island, 02886, United States

  • Bergstrom Eye Research, LLC

    Fargo, North Dakota, 58103, United States

  • Center For Sight

    Henderson, Nevada, 89052, United States

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona, 85032, United States

  • Country Hills Eye Center

    Ogden, Utah, 84403, United States

  • Dovilan Wyatt MD, LLC

    Chicago, Illinois, 60619, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana, 46290, United States

  • Mountain View Eye Center

    Layton, Utah, 84041, United States

  • Oculus Research, Inc. at the Eye Care Center

    Raleigh, North Carolina, 27603, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16066, United States

  • Texan Eye/Keystone Research

    Austin, Texas, 78731, United States

  • The Eye Care Institute

    Louisville, Kentucky, 40206, United States

  • Total Eye Care, P.A.

    Memphis, Tennessee, 38119, United States

  • Vision Institute

    Colorado Springs, Colorado, 80907, United States

  • Visual Eyes Optometric

    Shelby, North Carolina, 28150, United States

  • Whitson Vision

    Indianapolis, Indiana, 46240, United States

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