An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Start Date
12/1/2025
Completion Date
5/1/2027
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.
Detailed Description
The study will consist of 3 periods: 1. Screening period (from Day -7 ± 1 to Day 1), 2. Treatment Period (from randomization through Week12) and 3. Follow-up period (Weeks 13 to 16).
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
DFL24498
Vehicle
dexamethasone sodium phosphate (DSP) ophthalmic solution
Conditions
Locations
Bowden Eye Associates - Southside Location
Jacksonville, Florida 32256
United States
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida 33136
United States
Clayton Eye Clinical Research
Morrow, Georgia 30260
United States
Ophthalmology Associates
St Louis, Missouri 63131
United States
NYU Langone Health - Eye Center
New York, New York 10017
United States
Duke Eye Center - Ophthalmology
Durham, North Carolina 27710
United States
Total Eye Care, PA
Memphis, Tennessee 38119
United States
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology
Houston, Texas 77030
United States
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia
Bologna, 40138
Italy
Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti
Chieti, 66100
Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
Italy
AOU Policlinico Umberto I
Roma, 00161
Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134
Italy
METAVISION ARRUZAFA S.L. (Hospital Arruzafa)
Córdoba, 14012
Spain
Miranza Galicia
Santiago de Compostela, 15706
Spain
Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)
Valencia, 46015
Spain
OBA - Universidad de Valladolid
Valladolid, 47011
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain