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NCT07224529
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Conditions: Meibomian Gland Dysfunction (MGD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 48
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility Birmingham Alabama
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07224529). StuddyBuddy aggregates publicly available trial information.