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

The University of Alabama at Birmingham

Status and phase: Not yet enrolling; Phase 4

Conditions: Meibomian Gland Dysfunction (MGD)

Treatments: Drug: Vevye(Cyclosporine 0.1% Ophthalmic Solution)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07224529

300015544

Details and patient eligibility

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). 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.

Full 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,

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Drug: Vevye(Cyclosporine 0.1% Ophthalmic Solution)