An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

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.

NCT Number	NCT07503886
Lead Sponsor	Dompé Farmaceutici S.p.A
Conditions	Dry Eye Disease (DED)
Enrollment	417 participants
Start Date	2026-05-12
Primary Completion	2027-01-24 (estimated)
Study Completion	2027-02-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-26