NCT07224529 · University of Alabama at Birmingham
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
What this study is about
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).
View original scientific description
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.
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.
Primary outcome measures
Change in Meibomian Gland Expressibility Score
Time frame: Baseline to Week 24 (±1 week)
Meibomian gland function will be quantified using a standardized Meibomian Gland Evaluator. Expressibility is graded based on the quality and quantity of expressed meibum from five glands in each lid region. The change in mean expressibility score from baseline to Week 24 will determine improvement in gland function with Vevye® therapy. The Modified Meibomian Gland Expressibility Score grades five temporal, central, and nasal glands of the lower eyelid (15 glands total) using the following scale: 0 = clear meibum expressed, fluid; 1 = granular or cloudy meibum expressed, fluid; 2 = whitish/yellowish meibum expressed, semisolid or solid; 3 = no meibum expressed. Scores are summed across the 15 glands. Minimum Value: 0 Maximum Value: 45 Interpretation: Higher scores indicate worse meibomian gland function (poorer quality or absent secretion), and lower scores indicate better meibomian gland function.
Change in Visual Analog Scale (VAS) Dryness Score
Time frame: Baseline to Week 24 (±1 week)
The VAS Dryness assessment measures both the frequency ("rarely" to "all the time") and severity ("very mild" to "very severe") of eye dryness symptoms using 0-100 point horizontal sliders. Each participant's change from baseline to Week 24 will be analyzed to evaluate improvement in subjective dryness associated with meibomian gland dysfunction (MGD).
Change in Corneal Fluorescein Staining (NEI Scale)
Time frame: Baseline to Week 24 (±1 week)
Corneal fluorescein staining evaluates epithelial integrity of the cornea using the NEI/Industry scale. Five corneal zones are graded (0-3 each; total 0-15 per eye). The mean change in total corneal fluorescein staining score from baseline to Week 24 will assess ocular surface improvement following Vevye® treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion 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 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
- 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)
- Topical ocular steroids
- Any topical anti-glaucoma medication
- Any of the following procedural treatments for MGD within 6 months of enrollment:
- 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
Where
- Birmingham, Alabama
Collaborators
Harrow Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations