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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Meibomian Gland Dysfunction (MGD)
• Intervention / Treatment: Drug: Vevye(Cyclosporine 0.1% Ophthalmic Solution)

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,

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sindhu Gurrala, BDS, MPH; Phone Number: (205) 934-6734; Email: SOeyes@uab.edu
• Study Contact Backup: Name: UAB Optometry Clinical Research; Phone Number: 205-975-3881; Email: sgurral2@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
      • Contact: Sindhu Gurrala, BDS, MPH; Phone Number: 2059753881; Email: sgurral2@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: Vevye®; Cyclopsorine Ophthalmic Solution 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Baseline to Week 24 (±1 week)
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.	Baseline to Week 24 (±1 week)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Harrow Inc
• Investigators: Principal Investigator: Jillian F Ziemanski, OD, PhD, The University of Alabama at Birmingham, School of Optometry

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Actual): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: corneal staining; Dry Eye Disease; Meibomian Gland Dysfunction; Vevye; Ocular Surface Inflammation; Tear Film Instability
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Dry Eye Syndromes; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Ophthalmic Solutions
• Other Study ID Numbers: 300015544; Harrow, Inc. (Other Identifier: Harrow, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No