clinical trial · NCT07395232
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Dompé Farmaceutici S.p.A·phase3·recruiting·n = 138
Atopic KeratoconjunctivitisDFL24498Vehicledexamethasone sodium phosphate (DSP) ophthalmic solution
brief 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.
started
Dec 1, 2025
primary completion
Mar 1, 2027
completion
May 1, 2027
last updated
Apr 20, 2026
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).
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol