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Recruiting Phase 3 Interventional

An Efficacy and Safety Study of DFL24498 in the Treatment of AKC

ClinicalTrials.gov ID: NCT07395232

Public ClinicalTrials.gov record NCT07395232. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Participants With Atopic Keratoconjunctivitis (AKC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.

Study identification

NCT ID
NCT07395232
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Dompé Farmaceutici S.p.A
Industry
Enrollment
153 participants

Conditions and interventions

Eligibility (public fields only)

Age range
10 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 1, 2025 (Actual)
Primary completion
Mar 2027 (Estimated)
Completion
May 2027 (Estimated)
Last update posted
Sep 21, 2026

2025 – 2027

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
Bowden Eye Associates - Southside Location Jacksonville Florida 32256 Recruiting
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute Miami Florida 33136 Recruiting
Clayton Eye Clinical Research Morrow Georgia 30260 Recruiting
Ophthalmology Associates St Louis Missouri 63131 Recruiting
NYU Langone Health - Eye Center New York New York 10017 Recruiting
Duke Eye Center - Ophthalmology Durham North Carolina 27710 Recruiting
Total Eye Care, PA Memphis Tennessee 38119 Recruiting
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07395232, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07395232 live on ClinicalTrials.gov.

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