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RECRUITING
NCT07395232
PHASE3

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

Sponsor: Dompé Farmaceutici S.p.A

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-12-01

Completion Date

2027-05

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DRUG

DFL24498

DFL24498 will be instilled in each eye for 12 Weeks.

DRUG

Vehicle

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

DRUG

dexamethasone 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