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NOT YET RECRUITING

NCT07224529

PHASE4

Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

This research study evaluates a prescription eye drop called Vevye® (cyclosporine 0.1%) for adults who have meibomian gland dysfunction (MGD), a common eye condition that can cause dry, irritated, or burning eyes. If you join the study, after a short "run-in" period using artificial tears, you will receive Vevye twice a day for about 24 weeks (approximately six months). During that time you will attend several clinic visits where your eye symptoms, lid health, tear film, and meibomian gland function will be assessed. The goal is to learn whether Vevye improves symptoms (like eye dryness or irritation) and signs (such as changes on the eye's surface or lid margins) of MGD. You will also be monitored for safety and comfort of the eye drop. The information obtained from this study may help determine whether this treatment is beneficial for people with this condition and contribute to future care options. Participation is voluntary and you may stop at any time.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2027-02-01

Last Updated

2026-03-16

Healthy Volunteers

Conditions

Meibomian Gland Dysfunction (MGD)

Interventions

DRUG

Vevye(Cyclosporine 0.1% Ophthalmic Solution)

Participants will administer Vevye® (cyclosporine 0.1% ophthalmic solution) twice daily in both eyes for 24 weeks following a 2-week run-in period using a commercially available artificial tear. Vevye® contains cyclosporine, a calcineurin inhibitor that reduces ocular surface inflammation, dissolved in a semifluorinated alkane vehicle (perfluorobutylpentane, F4H5), which is preservative-free, water-free, and has no associated pH or osmolarity. The formulation is designed to enhance tear stability and reduce inflammatory processes associated with meibomian gland dysfunction (MGD). All participants receive the same treatment in this non-randomized, open-label, single-group interventional trial evaluating the efficacy and safety of Vevye® for MGD.

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

Locations (1)

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

Birmingham, Alabama, United States