Dry Eye
Conditions
Keywords
Dry Eye Disease, Ocular Surface Disease, Vevye, Flarex, Fluorometholone
Brief summary
This study evaluates the safety and efficacy of combination therapy with Vevye (cyclosporine ophthalmic solution) and Flarex (fluorometholone acetate ophthalmic suspension) in adults with moderate to severe dry eye disease. Participants receive Vevye twice daily and Flarex four times daily, with outcomes assessed over a 1-month period.
Detailed description
Dry eye disease is a multifactorial disorder characterized by inflammation and tear film instability. Vevye is a cyclosporine formulation designed to enhance ocular surface penetration and tolerability. Flarex is a corticosteroid with a lower risk of intraocular pressure elevation compared to traditional steroids. Combination therapy may accelerate symptom relief and improve tear film stability. This prospective, open-label, single-arm study evaluates the clinical outcomes of BID Vevye and QID Flarex over multiple visits, including Screening, Baseline, Day 3, Week 1, and Month 1. Both eyes are treated, with the study eye defined by the worse baseline VAS score.
Interventions
Vevye (cyclosporine ophthalmic solution) is administered twice daily (BID) in both eyes for the treatment of dry eye disease.
DRUGFlarex
Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes. Doses are separated from Vevye by approximately 10 minutes.
Sponsors
Canyon City Eyecare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults ≥18 years VAS ≥30 mm (moderate-severe dry eye) Able to provide informed consent Women of childbearing potential must meet contraception requirements \-
Exclusion criteria
* Uncontrolled systemic disease Ocular surgery/trauma within 12 months Punctal plugs \<6 months Active ocular infection/inflammation Recent lid heating therapy (\<6 months) Pregnant or breastfeeding Use of topical ocular meds after screening Significant corneal disease Systemic meds causing dry eye (e.g., antihistamines, antidepressants) Intraocular pressure \>21 mmHg or glaucoma history Contact lens use within 7 days Substance abuse within 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | Baseline to 1 Month | Change in Visual Analog Scale (VAS) Score |
Countries
United States
Outcome results
None listed