New eye drop trial offers hope for chronic dry eye sufferers
NCT ID NCT07224529
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
RECRUITINGBirmingham, Alabama, 35294, United States
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