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

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.

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.

Eligibility Criteria

Interventions