Dompé Farmaceutici S.p.A
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.
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).
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Men or women aged ≥ 18 and ≤ 65 years of age. 2. Diagnosis of AKC in both eyes, including the presence or medical history of the following: 1. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND 2. chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis. 3. Ocular itching of at least 50 as assessed by VAS scale. 4. Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulb…
DFL24498 will be instilled in each eye for 12 Weeks.
Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
Rescue medication may be administered as required at the Investigator discretion.