Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Recruiting now · Phase 4
Conditions studied: Meibomian Gland Dysfunction (MGD)
In brief
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 facts
- Study ID
- NCT07224529
- Run by
- University of Alabama at Birmingham
- People needed
- 48
- Starts
- 2026-06-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years
- VAS Dryness > 70
- Posterior lid margin hyperemia grade 2 or worse for both eyes
- Corneal fluorescein staining > 6 (NEI scale) for at least one eye
- Modified meibomian gland expression score ≥ 23 for both eyes OR ≥ 7 for expressible glands for both eyes OR a combination of the two
- Unanesthetized Schirmer ≥ 5 mm in 5 minutes for both eyes
You may not qualify if…
- Age > 18 years
- VAS Dryness > 70
- Posterior lid margin hyperemia grade 2 or worse for both eyes
- Corneal fluorescein staining > 6 (NEI scale) for at least one eye
- Modified meibomian gland expression score ≥ 23 for both eyes OR ≥ 7 for expressible glands for both eyes OR a combination of the two
- Unanesthetized Schirmer ≥ 5 mm in 5 minutes for both eyes
- 2 EXCLUSION CRITERIA
- Contact lens wear within two weeks of study enrollment or planned during study period
- Habitual visual acuity worse than 0.30 logMAR in either eye
- Previous or current diagnosis of any of the following conditions:
- Sjögren's disease
- Stevens-Johnson syndrome
- Keratoconus
- Herpetic keratitis
- Pterygium
- Any other condition that in the opinion of the clinician would interfere with study parameters
- Use of any of the following medications within 30 days of enrollment:
- Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions)
- Xiidra®
- Miebo®
- Tyrvaya
- Tryptyr®
- Topical ocular steroids
- Any topical anti-glaucoma medication
- Any of the following procedural treatments for MGD within 6 months of enrollment:
Where it is running
- University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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