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NCT07395232 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
A Phase 3 study of Atopic Keratoconjunctivitis, sponsored by Dompé Farmaceutici S.p.A.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 138
- Enrollment target
- 19
- Study locations
NCT07395232: Recruiting Phase 3 study of Atopic Keratoconjunctivitis, sponsored by Dompé Farmaceutici S.p.A.
NCT07395232 is a Phase 3 study of Atopic Keratoconjunctivitis that is actively recruiting participants, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 138 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). The trial reports 19 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07395232, a Phase 3 study of Atopic Keratoconjunctivitis, is actively recruiting participants, sponsored by Dompé Farmaceutici S.p.A.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 138 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
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 |
What NCT07395232 shows while recruiting
NCT07395232 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
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.
NCT07395232 lists 19 locations in 8 states (Other, Florida, Georgia).
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.
What interventions are being tested in trial NCT07395232?
The interventions under investigation include: Vehicle (DRUG), DFL24498 (DRUG), dexamethasone sodium phosphate (DSP) ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT07395232?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07395232's enrollment target sits among peer trials
138 1578th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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