A Phase 4 interventional study of Vevye(Cyclosporine 0.1% Ophthalmic Solution) in Meibomian Gland Dysfunction (MGD), sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
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.
This study is a non-randomized, open-label, interventional clinical trial designed to evaluate the efficacy of Vevye® (cyclosporine 0.1% ophthalmic solution) for the treatment of clinically significant meibomian gland dysfunction (MGD).
The study begins with a two-week run-in period during which participants use a commercially available artificial tear, followed by a 24-week intervention phase with Vevye® dosed twice daily in both eyes. Clinical examinations occur at screening (Day -14), baseline (Day 0), and at Days 28, 84, and 168.
Approximately 48 adults (age ≥ 18 years) with clinically significant MGD will be enrolled at the University of Alabama at Birmingham, School of Optometry. Each participant will complete five study visits over about six months, lasting approximately 50 to 90 minutes each.
At each visit, standardized ocular assessments are performed, including:
Visual Analog Scale (VAS) Dryness survey,
Habitual visual acuity under high- and low-contrast conditions,
Slit-lamp biomicroscopy and evaluation of posterior lid margin hyperemia,
Fluorescein tear breakup time, corneal fluorescein staining, and conjunctival staining with lissamine green,
Lid wiper epitheliopathy evaluation,
Meibomian gland expression using the Meibomian Gland Evaluator,
Infrared keratograph meibography, and
Schirmer I test without anesthesia.
Primary endpoints include change from baseline to Week 24 in VAS dryness, corneal fluorescein staining (NEI scale), and meibomian gland expressibility. Exploratory endpoints include posterior lid margin hyperemia, lid wiper epitheliopathy, contrast sensitivity, low-contrast visual acuity, fluorescein tear breakup time, conjunctival staining, and gland dropout by meibography.
Participants are trained on dosing technique and use of a dosing diary. Product accountability and log review occur at every visit to monitor compliance. Adverse events are recorded throughout the study, and early termination may occur if clinically indicated.
The most common expected side effects are mild, transient burning, stinging, redness, or blurred vision after instillation. Participants are instructed not to use Vevye® while wearing contact lenses.
There are no direct benefits guaranteed from participation, although some individuals may experience improvement in eye comfort or tear quality. The findings may help determine whether Vevye® is effective for people with MGD and contribute to developing better treatment options for this condition.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
4.2 EXCLUSION CRITERIA
Previous or current diagnosis of any of the following conditions:
Use of any of the following medications within 30 days of enrollment:
Any of the following procedural treatments for MGD within 6 months of enrollment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 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. All participants will undergo standardized ocular assessments including Visual Analog Scale (VAS) dryness, visual acuity (high- and low-contrast), slit-lamp biomicroscopy, posterior lid margin hyperemia, fluorescein tear breakup time, corneal fluorescein staining, conjunctival staining with lissamine green, lid wiper epitheliopathy, meibomian gland expression, keratograph meibography, and Schirmer I test. This is a non-randomized, open-label, single-group study evaluating the efficacy and safety of Vevye® for the treatment of clinically significant meibomian gland dysfunction
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.
Also known as: Vevye®, Cyclopsorine Ophthalmic Solution 0.1%
Change in Meibomian Gland Expressibility Score
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.
Time frame: Baseline to Week 24 (±1 week)
Change in Visual Analog Scale (VAS) Dryness Score
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).
Time frame: Baseline to Week 24 (±1 week)
Change in Corneal Fluorescein Staining (NEI Scale)
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.
Time frame: Baseline to Week 24 (±1 week)
Plan to share: No — Individual participant data (IPD) will not be shared outside of the study team, sponsor, or regulatory agencies. Participant data will be used only for analysis related to this study and may be reviewed by authorized representatives of the sponsor (Harrow, Inc.), the University of Alabama at Birmingham Institutional Review Board (IRB), and regulatory authorities as required by law. De-identified summary results may be shared in aggregate form in publications or presentations, but no individual-level data will be made publicly available.
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Studies of the drug tested here: Cyclosporine
University of Alabama at Birmingham →