Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
University of Alabama at Birmingham
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.
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 s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Modifie…
Interventions
- DrugVevye(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.
Location
- University of Alabama at Birmingham, School of Optometry, Clinical Eye Research FacilityBirmingham, Alabama