Study detail
RecruitingPhase 3
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)
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. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers