Not Yet RecruitingPhase 2

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

417 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Schirmer I test without anesthesia \< 10 mm/5 minutes, and
✓. Total CFS grade ≥ 4 assessed by the NEI grading system, and
✓. Fluorescein tear film break-up time (TFBUT) \< 10 seconds.

What they're measuring

Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07503886

SponsorDompé Farmaceutici S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-24

Contact for this trial

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

+39 02 583 831

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials