Vevye + Flarex Combination Therapy for Dry Eye

NCT07553455 | Enrolling By Invitation Phase 4 FDA Drug

• 2 other identifiers: VEV-FLX-2025-0115573-MMHom
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Dry Eye Disease; Ocular Surface Disease; Vevye; Flarex; Fluorometholone

Outcome Measures

Primary Outcomes (1)

• VAS

  Change in Visual Analog Scale (VAS) Score

  Baseline to 1 Month

Study Arms (1)

Combination Therapy Arm

EXPERIMENTAL

Participants receive Vevye (cyclosporine ophthalmic solution) twice daily and Flarex (fluorometholone acetate ophthalmic suspension) four times daily.

Drug: Vevye(Cyclosporine 0.1% Ophthalmic Solution); Drug: Flarex

Interventions

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.

Combination Therapy Arm

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.

Combination Therapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Canyon City Eyecare: lead

Study Sites (1)

Canyon City Eyecare

Azusa, California, 91702, United States

Location

Related Publications (3)

• Pflugfelder SC, Stern ME. Biological functions of tear film. Exp Eye Res. 2020 Aug;197:108115. doi: 10.1016/j.exer.2020.108115. Epub 2020 Jun 16.

  PMID: 32561483 BACKGROUND

• Sullivan DA, Rocha EM, Aragona P, Clayton JA, Ding J, Golebiowski B, Hampel U, McDermott AM, Schaumberg DA, Srinivasan S, Versura P, Willcox MDP. TFOS DEWS II Sex, Gender, and Hormones Report. Ocul Surf. 2017 Jul;15(3):284-333. doi: 10.1016/j.jtos.2017.04.001. Epub 2017 Jul 20.

  PMID: 28736336 BACKGROUND

• Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

  PMID: 28736335 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions; Fluorometholone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optometrist

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 28, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)