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NCT07503886PHASE2Recruiting

An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

Dompé Farmaceutici S.p.A

Start Date

5/12/2026

Completion Date

2/7/2027

Summary

This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye). * The global score of the SANDE questionnaire ≥ 30 * DED in at least one eye which is characterized by the following clinical features: 1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and 2. Total CFS grade ≥ 4 assessed by the NEI grading system, and 3. Fluorescein tear film break-up time (TFBUT) \< 10 seconds. * Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \[LogMAR\]) in each eye at the time of study enrollment. * Only participants who satisfy all informed consent requirements will be included in the study. Key Exclusion Criteria: * Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments. * Evidence of an active ocular infection in either eye. * Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening. * Intraocular inflammation defined as anterior chamber cell or flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye. * Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye. Note: Additional protocol defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

DFL24498

OTHER

Vehicle

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Conditions

Dry Eye Disease (DED)

Locations

Arizona Eye Center

Chandler, Arizona 85224

United States

Canyon City Eyecare

Azusa, California 91702

United States

Global Research Management, Inc.

Glendale, California 91204

United States

United Medical Research Institute

Inglewood, California 90301

United States

LoBue Laser and Eye Medical Center

Murrieta, California 82562

United States

Eye Research Foundation

Newport Beach, California 92663

United States

NVision Clinical Research, LLC

Torrance, California 90505

United States

Shettle Eye Research, Inc.

Largo, Florida 33773

United States

University of South Florida - Marshall Student Center

Tampa, Florida 33612

United States

Clayton Eye Clinical Research

Morrow, Georgia 30260

United States

Price Vision Group / Cornea Research Foundation of America

Indianapolis, Indiana 46260

United States

Minnesota Eye Consultants

Minnetonka, Minnesota 55305

United States

Tekwani Vision Center

St Louis, Missouri 63128

United States

Comprehensive Eye Care, Ltd.

Washington, Missouri 63090

United States

Asheville Eye Associates - Regional Medical Park

Asheville, North Carolina 28803

United States

Oculus Research, Inc.

Garner, North Carolina 27529

United States

Core, Inc.

Shelby, North Carolina 28150

United States

Cincinnati Eye Institute

Mason, Ohio 45040

United States

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania 16066

United States

Total Eye Care, PA - Memphis

Memphis, Tennessee 38119

United States

Houston Eye Associates

Houston, Texas 77025

United States

Lake Travis Eye and Laser Center

Lakeway, Texas 78738

United States

Alpine Research Organization, Inc.

Clinton, Utah 84015

United States

Piedmont Eye Center

Lynchburg, Virginia 24502

United States