Phase 3 Study to Test Safety and Effectiveness of DFL24498 Eye Drops in Adults With Atopic Keratoconjunctivitis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of DFL24498 eye drops compared with a placebo solution in adults with Atopic Keratoconjunctivitis AKC, a condition involving inflammation and itching of the eyes. This phase 3, multicenter, randomized, double-masked study will include approximately 138 participants who meet specific criteria. The trial is sponsored by Domp Farmaceutici S.p.A and aims to provide detailed information about this treatment for AKC. The study has three main periods a screening period lasting up to one week before treatment, a 12-week treatment period where participants receive either DFL24498 or vehicle eye drops in both eyes, and a follow-up period lasting from week 13 to week 16. Rescue medication with dexamethasone sodium phosphate ophthalmic solution may be given if needed. The trial uses a randomized and triple-masked design to compare the study drug against a placebo. Participants will undergo various assessments including ocular itching scores, corneal staining, conjunctival redness, and other eye condition signs at multiple points during the study. Quality of life and patient-reported changes will also be measured. Safety will be monitored through adverse event reporting and visual acuity tests. The total participation duration spans from screening through the follow-up period, about 16 weeks in all.

An Efficacy and Safety Study of DFL24498 in the Treatment of AKC