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New eye drop trial offers hope for chronic dry eye sufferers

NCT ID NCT07224529

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a prescription eye drop called Vevye (cyclosporine 0.1%) in 48 adults with meibomian gland dysfunction (MGD), a common cause of dry, burning eyes. Participants use the drops twice daily for 24 weeks, and researchers measure changes in eye symptoms, gland function, and eye surface health. The goal is to see if Vevye can improve both symptoms and signs of MGD, potentially offering a new treatment option.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 48 people

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

Started

Jun 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Age \> 18 years 2. VAS Dryness \> 70 3. Posterior lid margin hyperemia grade 2 or worse for both eyes 4. Corneal fluorescein staining \> 6 (NEI scale) for at least one eye 5. Modified meibomian gland expression score ≥ 23 for both eyes OR ≥ 7 for expressible glands for both eyes OR a combination of the two 6. Unanesthetized Schirmer ≥ 5 mm in 5 minutes for both eyes Exclusion Criteria: 1. Age \> 18 years 2. VAS Dryness \> 70 3. Posterior lid margin hyperemia grade 2 or worse for both eyes 4. Corneal fluorescein staining \> 6 (NEI scale) for at least one eye 5. Modified meibomian gland expression score ≥ 23 for both eyes OR ≥ 7 for expressible glands for both eyes OR a combination of the two 6. Unanesthetized Schirmer ≥ 5 mm in 5 minutes for both eyes 4.2 EXCLUSION CRITERIA 1. Contact lens wear within two weeks of study enrollment or planned during study period 2. Habitual visual acuity worse than 0.30 logMAR in either eye 3. Previous or current diagnosis of any of the following conditions: 1. Sjögren's disease 2. Stevens-Johnson syndrome 3. Keratoconus 4. Herpetic keratitis 5. Pterygium 6. Any other condition that in the opinion of the clinician would interfere with study parameters 4. Use of any of the following medications within 30 days of enrollment: 1. Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions) 2. Xiidra® 3. Miebo® 4. Tyrvaya 5. Tryptyr® 6. Topical ocular steroids 7. Any topical anti-glaucoma medication 5. Any of the following procedural treatments for MGD within 6 months of enrollment: 1. LipiFlow® 2. TearCare® 3. iLux® 4. Intense pulsed light (IPL) 5. Therapeutic gland expression 6. Any other procedure targeting the meibomian glands 6. Insertion or removal of permanent punctal plugs within 3 months of enrollment 7. Insertion of dissolvable punctal plugs within 9 months of enrollment (or within 3 months of expected dissolution date, if known) 8. Presence of active ocular allergies 9. Previous intraocular surgery within 6 months of enrollment 10. Previous refractive surgery within 2 years of enrollment 11. Current or planned pregnancy during the study period 12. Current or planned lactation during the study period 13. Females of childbearing potential who are not using effective contraception 14. Known allergy or sensitivity to the study drug 15. Dose modification of oral antihistamines or antidepressants within 1 month of enrollment 16. Current enrollment or enrollment within 60 days in any other study of an investigational drug or device 17. Clinical opinion of the study doctor based on clinical examination and/or participant compliance with protocol requirements

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Conditions

The condition(s) this trial relates to.

dry eye syndrome Meibomian Gland Dysfunction

As listed by the trial registrant

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

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

  • University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility

    RECRUITING

    Birmingham, Alabama, 35294, United States

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