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

Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (NCT07224529) is a Phase 4 interventional studying Meibomian Gland Dysfunction (MGD), sponsored by University of Alabama at Birmingham. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

Birmingham, Alabama, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07224529), the sponsor (University of Alabama at Birmingham), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07224529 clinical trial studying?

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 ir… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07224529?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07224529?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07224529. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07224529. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.