Vevye eye drops for meibomian gland dysfunction in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4, open-label investigation evaluating the safety and efficacy of cyclosporine 0.1% eye drops for adults with MGD. After a brief run-in with artificial tears, participants apply Vevye twice daily in both eyes for about 24 weeks and attend multiple clinic visits to monitor symptoms, lid health, tear film stability, and gland function. Assessments include patient-reported dryness, visual acuity, tear film tests, lid margin evaluation, and meibomian gland measures. The trial collects safety data and aims to determine whether Vevye can improve both subjective symptoms and objective signs of MGD. Participation is voluntary and withdrawal is possible at any time.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Jillian F Ziemanski, OD, PhD — The University of Alabama at Birmingham, School of Optometry
• Study coordinator: Sindhu Gurrala, BDS, MPH
• Email: SOeyes@uab.edu
• Phone: (205) 934-6734

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sleep Better, Live Better: a 12-week coaching program to help adults improve sleep and heart-brain health

  This trial tests a 12-week, telephone- and text-based sleep coaching program for adults 25–65 with short sleep and higher cardiometabolic risk to see if it improves sleep and related behaviors.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07862348

• Community health worker support to lower blood pressure after pregnancy with high blood pressure

  Postpartum patients with high blood pressure after pregnancy will try a program where a trained community health worker helps them monitor blood pressure and manage care for 6 months to see if it lowers blood pressure compared with usual care.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07778966

• Improving Care for underserved older Black patients with cardiovascular and other chronic conditions

  This study tests a culturally tailored approach to patient-centered care for older African American patients with cardiovascular disease and other conditions who receive care at a community hospital.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07748858

• See if deep brain stimulation for Parkinson's changes thinking and movement and affects fall risk

  This pilot study tests whether deep brain stimulation in people with Parkinson’s changes thinking or movement and whether those changes relate to how often they fall.

  Recruiting University of Alabama at Birmingham · Homewood, Alabama · NCT07725315

• Finance-focused psycho-oncology support for cancer patients experiencing financial hardship

  This pilot tests whether two monthly 60-minute finance-focused counseling sessions over three months can help cancer patients who are experiencing financial distress.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07724041

• Nutrition education before arthroscopic knee or shoulder surgery

  This study tests whether watching a nutrition education video before arthroscopic knee or shoulder surgery helps patients’ recovery by comparing those who viewed the video to those who did not.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07723742

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.