A 12-Week Phase 2 Study of DFL24498 0.08% Eye Drops Compared to Placebo for Treating Dry Eye Disease

What this Trial Is About

Researchers are evaluating the efficacy and safety of DFL24498, a topical ophthalmic solution, compared with a vehicle solution in adults with dry eye disease. This Phase 2, randomized, double-masked, vehicle-controlled study will enroll about 417 participants aged 18 years or older across multiple centers in the US. The study duration is up to 16 weeks and consists of three distinct periods. Participants are assigned to receive either DFL24498 or the vehicle solution, both administered as one drop in each eye four times daily for 12 weeks. The study includes a vehicle-controlled parallel group design. After the 12-week treatment period, there is a 2-week follow-up phase to monitor safety and outcomes. Throughout the study, participants will undergo assessments including corneal fluorescein staining, ocular dryness symptom evaluation using the SANDE questionnaire, tear production measurement with the Schirmer I test, and conjunctival fluorescein staining. Researchers will also track treatment-emergent adverse events. The primary outcome focuses on the change in corneal staining from baseline to week 12, with safety monitored during and after treatment.

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