NCT07503886

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

A 12-Week, Phase 2, Multicenter, Randomized, Double-Masked, Vehicle Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate the Efficacy and Safety of DFL24498 0.08% Topical Ophthalmic Solution Versus Vehicle in Participants With Dry Eye Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 417 (estimated)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	DFL24498	One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
OTHER	Vehicle	One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-01-24
• Completion: 2027-02-07
• First posted: 2026-03-31
• Last updated: 2026-03-31

Regulatory

• FDA-regulated drug study
• FDA-regulated device study