Vevye + Flarex Combination Therapy for Dry Eye (FLARE-VEV)

April 22, 2026 updated by: Milton Hom, Canyon City Eyecare

Combination Therapy of Vevye and Flarex for Dry Eye Disease

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Azusa, California, United States, 91702
        • Canyon City Eyecare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Therapy Arm
Participants receive Vevye (cyclosporine ophthalmic solution) twice daily and Flarex (fluorometholone acetate ophthalmic suspension) four times daily.
Drug: Vevye(Cyclosporine 0.1% Ophthalmic Solution)
Vevye (cyclosporine ophthalmic solution) is administered twice daily (BID) in both eyes for the treatment of dry eye disease.
Drug: Flarex
Flarex (fluorometholone acetate ophthalmic suspension) is administered four times daily (QID) in both eyes. Doses are separated from Vevye by approximately 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: Baseline to 1 Month
Change in Visual Analog Scale (VAS) Score
Baseline to 1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canyon City Eyecare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEV-FLX-2025-01
  • 15573-MMHom (Other Identifier: Sterling IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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