Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
NCT07395232 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG DFL24498
- DRUG dexamethasone sodium phosphate (DSP) ophthalmic solution
Study Locations (19)
Other
- IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia — Bologna
- Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti — Chieti
- Azienda Ospedaliero Universitaria Careggi — Florence
- Fondazione Policlinico Universitario Campus Bio-Medico — Roma
- AOU Policlinico Umberto I — Roma
- Azienda Ospedaliera Universitaria Integrata Verona — Verona
- METAVISION ARRUZAFA S.L. (Hospital Arruzafa) — Córdoba
- Miranza Galicia — Santiago de Compostela
- Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM) — Valencia
- OBA - Universidad de Valladolid — Valladolid
- Hospital Universitario Miguel Servet — Zaragoza
Florida
- Bowden Eye Associates - Southside Location — Jacksonville
- University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute — Miami
Georgia
- Clayton Eye Clinical Research — Morrow
Missouri
- Ophthalmology Associates — St Louis
New York
- NYU Langone Health - Eye Center — New York
North Carolina
- Duke Eye Center - Ophthalmology — Durham
Tennessee
- Total Eye Care, PA — Memphis
Texas
- Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2027-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07395232
The ClinicalTrials.gov registry entry for NCT07395232 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atopic Keratoconjunctivitis appearing as the primary indexed condition, and to 3 interventions — of which Vehicle is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07395232 reports 19 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07395232 about?
NCT07395232 is a clinical study titled "An Efficacy and Safety Study of DFL24498 in the Treatment of AKC". This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled i...
What is the current status of trial NCT07395232?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2025-12-01. Estimated completion is 2027-05.
What conditions does trial NCT07395232 study?
This clinical trial studies the following conditions: Atopic Keratoconjunctivitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07395232?
The interventions under investigation include: Vehicle (DRUG), DFL24498 (DRUG), dexamethasone sodium phosphate (DSP) ophthalmic solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07395232?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07395232 being conducted?
This trial has 19 study locations across Florida, Georgia, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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