Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in Meibomian Gland Expressibility Score
Study Overview
Brief 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.
Detailed Description
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,
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
All participants, investigators, and study staff will know the treatment being administered. No masking or blinding procedures are implemented.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
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
Intervention: Vevye(Cyclosporine 0.1% Ophthalmic Solution) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jillian Ziemanski
Associate Professor
University of Alabama at Birmingham