Dompé Farmaceutici S.p.A
This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.
Key Inclusion Criteria: * A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye). * The global score of the SANDE questionnaire ≥ 30 * DED in at least one eye which is characterized by the following clinical features: 1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and 2. Total CFS grade ≥ 4 assessed by the NEI grading system, and 3. Fluorescein tear film break-up time (TFBUT) \< 10 seconds. * Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) char…
One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.