Recruiting

Vevye®

Sponsor:

University of Alabama at Birmingham

Code:

NCT07224529

Conditions

Meibomian Gland Dysfunction (MGD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vevye(Cyclosporine 0.1% Ophthalmic Solution)

Study Details

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.

Conditions

Meibomian Gland Dysfunction (MGD)

Study ID

NCT07224529

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

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 measure

  • Change in Meibomian Gland Expressibility Score [ Time Frame: Baseline to Week 24 (±1 week) ]
  • Change in Visual Analog Scale (VAS) Dryness Score [ Time Frame: Baseline to Week 24 (±1 week) ]
  • Change in Corneal Fluorescein Staining (NEI Scale) [ Time Frame: Baseline to Week 24 (±1 week) ]

Central Contacts and Locations

Central contacts

Sindhu Gurrala, BDS, MPH

(205) 934-6734SOeyes@uab.edu

UAB Optometry Clinical Research

205-975-3881sgurral2@uab.edu

Locations

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

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Sindhu Gurrala, BDS, MPH

2059753881sgurral2@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • corneal staining
  • Meibomian Gland Dysfunction
  • Dry Eye Disease
  • Ocular Surface Inflammation
  • Tear Film Instability
  • Vevye

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-09.