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

RecruitingPhase 3

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)

Who can join

Ages 10 to 65 · All sexes

Full eligibility criteria
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Male or Female aged ≥ 10 and ≤ 65 years.
2. Diagnosis of AKC in both eyes, including the presence or medical history of the following:

   1. other atopic condition (ie., atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
   2. chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
3. Ocular itching of at least 50 as assessed by VAS scale.
4. Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
5. A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).
6. If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method.

Exclusion Criteria:

Participants will be excluded if any of the following criteria apply:

1. 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.
2. Evidence of an active ocular infection in either eye.
3. Intraocular inflammation defined as anterior chamber flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
4. Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
5. Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma.
6. Participants that are anatomically monocular.
7. Systemic disease not stabilized within 1 month before the screening visit (eg, diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (eg, current systemic infections) or with a condition incompatible with the frequent assessment required by the study.

Note: Additional protocol defined Inclusion/Exclusion criteria apply

About the study

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.

What is being tested

Sponsor: Dompé Farmaceutici S.p.A · Participants: 153 · Started: Dec 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07395232

Locations in the U.S.

FloridaBowden Eye Associates - Southside Location, Jacksonville
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute, Miami
GeorgiaClayton Eye Clinical Research, Morrow
MissouriOphthalmology Associates, St Louis
New YorkNYU Langone Health - Eye Center, New York
North CarolinaDuke Eye Center - Ophthalmology, Durham
TennesseeTotal Eye Care, PA, Memphis
TexasBaylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology, Houston

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.