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Tests treatment safety and results for Meibomian Gland Dysfunction (MGD)
Official title Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
ClinicalTrials.gov ID: NCT07224529
What this study is testing
What is Vevye(Cyclosporine 0.1% Ophthalmic Solution)?
Vevye(Cyclosporine 0.1% Ophthalmic Solution) is an investigational medicine, given as an once-daily, being studied as a potential treatment for meibomian gland dysfunction (mgd).
Also referred to as Vevye®, Cyclopsorine Ophthalmic Solution 0.1%.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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 4.2 EXCLUSION CRITERIA
See the full eligibility criteria
- 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
- 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 4.2 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:
- LipiFlow®
- TearCare®
- iLux®
- Intense pulsed light (IPL)
- Therapeutic gland expression
- Any other procedure targeting the meibomian glands
- Insertion or removal of permanent punctal plugs within 3 months of enrollment
- Insertion of dissolvable punctal plugs within 9 months of enrollment (or within 3 months of expected dissolution date, if known)
- Presence of active ocular allergies
- Previous intraocular surgery within 6 months of enrollment
- Previous refractive surgery within 2 years of enrollment
- Current or planned pregnancy during the study period
- Current or planned lactation during the study period
- Females of childbearing potential who are not using effective contraception
- Known allergy or sensitivity to the study drug
- Dose modification of oral antihistamines or antidepressants within 1 month of enrollment
- Current enrollment or enrollment within 60 days in any other study of an investigational drug or device
- Clinical opinion of the study doctor based on clinical examination and/or participant compliance with protocol requirements
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.