An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS). — Baseline and at Week 6
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Bowden Eye Associates - Southside Location | Jacksonville | Florida | Recruiting |
| University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute | Miami | Florida | Recruiting |
| Clayton Eye Clinical Research | Morrow | Georgia | Recruiting |
| Ophthalmology Associates | St Louis | Missouri | Recruiting |
| NYU Langone Health - Eye Center | New York | New York | Recruiting |
| Duke Eye Center - Ophthalmology | Durham | North Carolina | Recruiting |
| Total Eye Care, PA | Memphis | Tennessee | Recruiting |
| Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology | Houston | Texas | Recruiting |
| IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia | Bologna | Italy | Recruiting |
| Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti | Chieti | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Careggi | Florence | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico | Roma | Italy | Recruiting |
| AOU Policlinico Umberto I | Roma | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | Recruiting |
| METAVISION ARRUZAFA S.L. (Hospital Arruzafa) | Córdoba | Spain | Recruiting |
| Miranza Galicia | Santiago de Compostela | Spain | Recruiting |
| Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM) | Valencia | Spain | Recruiting |
| OBA - Universidad de Valladolid | Valladolid | Spain | Recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Recruiting |
More Dompé Farmaceutici S.p.A trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07395232 on ClinicalTrials.gov ↗ ← All trials in Italy