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An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Sponsor: Dompé Farmaceutici S.p.A
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. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.
Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Participants With Atopic Keratoconjunctivitis (AKC)
Key Details
Gender
All
Age Range
10 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2025-12-01
Completion Date
2027-05
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
DFL24498
DFL24498 will be instilled in each eye for 12 Weeks.
Vehicle
Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
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