RecruitingPhase 3NCT07395232

An Efficacy and Safety Study of DFL24498 in the Treatment of AKC

A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Adult Participants With Atopic Keratoconjunctivitis (AKC)


Sponsor

Dompé Farmaceutici S.p.A

Enrollment

138 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called DFL24498, a drug called Vehicle, and others for people with atopic keratoconjunctivitis. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDFL24498

DFL24498 will be instilled in each eye for 12 Weeks.

DRUGVehicle

Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.

DRUGdexamethasone sodium phosphate (DSP) ophthalmic solution

Rescue medication may be administered as required at the Investigator discretion.


Locations(19)

Bowden Eye Associates - Southside Location

Jacksonville, Florida, United States

University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute

Miami, Florida, United States

Clayton Eye Clinical Research

Morrow, Georgia, United States

Ophthalmology Associates

St Louis, Missouri, United States

NYU Langone Health - Eye Center

New York, New York, United States

Duke Eye Center - Ophthalmology

Durham, North Carolina, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology

Houston, Texas, United States

IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia

Bologna, Italy

Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti

Chieti, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy

AOU Policlinico Umberto I

Roma, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

METAVISION ARRUZAFA S.L. (Hospital Arruzafa)

Córdoba, Spain

Miranza Galicia

Santiago de Compostela, Spain

Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)

Valencia, Spain

OBA - Universidad de Valladolid

Valladolid, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT07395232