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

NCT07224529 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: 300015544Harrow, Inc.
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

Study Arms (1)

Treatment

EXPERIMENTAL

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)

Interventions

Vevye(Cyclosporine 0.1% Ophthalmic Solution) DRUG

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.

Also known as: Vevye®, Cyclopsorine Ophthalmic Solution 0.1%

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Pterygium
• Any other condition that in the opinion of the clinician would interfere with study parameters

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Harrow Inc: collaborator

Study Sites (1)

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

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Jillian F Ziemanski, OD, PhD

  The University of Alabama at Birmingham, School of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindhu Gurrala, BDS, MPH

CONTACT

(205) 934-6734; SOeyes@uab.edu

UAB Optometry Clinical Research

CONTACT

205-975-3881; sgurral2@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: All participants, investigators, and study staff will know the treatment being administered. No masking or blinding procedures are implemented.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a non-randomized, open-label, single-arm interventional study in which all participants receive Vevye® (cyclosporine 0.1%) twice daily in both eyes for 24 weeks following a 2-week artificial-tear run-in period.

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)