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Enrolling by Invitation

NCT Number: NCT07553455

Vevye + Flarex Combination Therapy for Dry Eye

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Canyon City Eyecare

Azusa, California, 91702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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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

Treatment and study plan

Vevye(Cyclosporine 0.1% Ophthalmic Solution)

Drug

Vevye (cyclosporine ophthalmic solution) is administered twice daily (BID) in both eyes for the treatment of dry eye disease.

Flarex

Drug

Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes. Doses are separated from Vevye by approximately 10 minutes.

Primary outcomes

  1. VAS

    Time frame: Baseline to 1 Month

    Change in Visual Analog Scale (VAS) Score

Sponsors and collaborators

Lead sponsor

Canyon City Eyecare

Other

Registry information

Official study title

Combination Therapy of Vevye and Flarex for Dry Eye Disease

Acronym: FLARE-VEV

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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