A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Participants With Atopic Keratoconjunctivitis (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 are eligible to be included in the study only if all of the following criteria apply:
• Male or Female aged ≥ 10 and ≤ 65 years.
• Diagnosis of AKC in both eyes, including the presence or medical history of the following:
‣ other atopic condition (ie., atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
⁃ chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
• Ocular itching of at least 50 as assessed by VAS scale.
• Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
• A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).
• If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method.