Status: Recruiting
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
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.
Participants needed: 153
Trial details
Phase: Phase 3Age: 10-65Biological sex: AllType: InterventionalSponsor: Dompé Farmaceutici S.p.AUpdated: Sep 21, 2026Locations: 19
Eligibility criteria
Male or Female aged ≥ 10 and ≤ 65 years. [+6]
Inability to speak and understand the local language sufficiently to understand... [+6]