An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Ve… (NCT07503886) | Clinical Trial Compass
RecruitingPhase 2
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
United States417 participantsStarted 2026-05-12
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new topical eye drop called DFL24498 against a vehicle control — what does 'vehicle' mean here, and does that mean some participants receive no active treatment for their dry eye during the study?
2Since this is a Phase 2 trial, what does that tell us about how much is already known regarding DFL24498's safety and effectiveness compared to dry eye treatments that are already approved?
3The trial is measuring improvement using the NEI corneal fluorescein staining scale, which assesses surface damage to the eye — can you help me understand what my current score on that scale is and whether that makes this trial worth discussing as an option for me?
4The trial isn't recruiting yet — given that timeline uncertainty, would it make more sense to start an existing approved treatment now and revisit this trial later, or could waiting potentially be worthwhile?
5Are there any aspects of my overall health history or current dry eye severity that might affect whether this kind of investigational topical solution would even be appropriate for me to discuss with the trial team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)