NCT07503886 An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
| NCT ID | NCT07503886 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dompé Farmaceutici S.p.A |
| Condition | Dry Eye Disease (DED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 417 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-01-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 417 participants in total. It began in 2026-05-12 with a primary completion date of 2027-01-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: * A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye). * The global score of the SANDE questionnaire ≥ 30 * DED in at least one eye which is characterized by the following clinical features: 1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and 2. Total CFS grade ≥ 4 assessed by the NEI grading system, and 3. Fluorescein tear film break-up time (TFBUT) \< 10 seconds. * Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \[LogMAR\]) in each eye at the time of study enrollment. * Only participants who satisfy all informed consent requirements will be included in the study. Key Exclusion Criteria: * Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments. * Evidence of an active ocular infection in either eye. * Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening. * Intraocular inflammation defined as anterior chamber cell or flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye. * Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye. Note: Additional protocol defined Inclusion/Exclusion criteria apply.
Contact & Investigator
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
📞 +39 02 583 831
Frequently Asked Questions
Who can join the NCT07503886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07503886 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07503886 currently recruiting?
Yes, NCT07503886 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dompé Farmaceutici S.p.A to inquire about joining.
Where is the NCT07503886 trial being conducted?
This trial is being conducted at Chandler, United States, Azusa, United States, Glendale, United States, Inglewood, United States and 11 additional locations.
Who is sponsoring the NCT07503886 clinical trial?
NCT07503886 is sponsored by Dompé Farmaceutici S.p.A. The trial plans to enroll 417 participants.