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NCT07503886 · ClinicalTrials.gov registry record · Phase 2
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 417
- Enrollment target
NCT07503886: Recruiting Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT07503886 is a Phase 2 study that is actively recruiting participants, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 417 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (214% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07503886, a Phase 2 study, is actively recruiting participants, sponsored by Dompé Farmaceutici S.p.A.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 417 participants
- Enrollment target
Study 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.
Primary Outcome
Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. The CFS is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores five corneal zones from 0 to 3 (total corneal score 0-15) with higher scores indicating more extensive staining.
Interventions
- OTHER Vehicle
- DRUG DFL24498
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2026-05-12 |
| Est. Completion | 2027-02-07 |
| Phase | Phase 2 |
What NCT07503886 shows while recruiting
NCT07503886 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (214% higher).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT07503886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07503886 about?
NCT07503886 is a clinical study titled "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 elig...
What is the current status of trial NCT07503886?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 417 participants. The study started on 2026-05-12. Estimated completion is 2027-02-07.
What interventions are being tested in trial NCT07503886?
The interventions under investigation include: Vehicle (OTHER), DFL24498 (DRUG).
Who is sponsoring clinical trial NCT07503886?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07503886's enrollment target sits among peer trials
417 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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