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Clinical Trials in the USA / NCT07395232
Recruiting Phase 3

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

NCT07395232 · tracked via the Priya Life Science USA tracker
Sponsor
Dompé Farmaceutici S.p.A
Phase
Phase 3
Started
2025-12-01
Last updated
2026-09-21

Condition(s) studied

Atopic Keratoconjunctivitis

Investigational drug(s) / intervention(s)

DFL24498Vehicledexamethasone sodium phosphate (DSP) ophthalmic solution

DFL24498: DFL24498 will be instilled in each eye for 12 Weeks.

Vehicle: Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.

dexamethasone sodium phosphate (DSP) ophthalmic solution: Rescue medication may be administered as required at the Investigator discretion.

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. 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Bowden Eye Associates - Southside Location Jacksonville Florida Recruiting
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute Miami Florida Recruiting
Clayton Eye Clinical Research Morrow Georgia Recruiting
Ophthalmology Associates St Louis Missouri Recruiting
NYU Langone Health - Eye Center New York New York Recruiting
Duke Eye Center - Ophthalmology Durham North Carolina Recruiting
Total Eye Care, PA Memphis Tennessee Recruiting
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology Houston Texas Recruiting
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia Bologna Italy Recruiting
Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti Chieti Italy Recruiting
Azienda Ospedaliero Universitaria Careggi Florence Italy Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico Roma Italy Recruiting
AOU Policlinico Umberto I Roma Italy Recruiting
Azienda Ospedaliera Universitaria Integrata Verona Verona Italy Recruiting
METAVISION ARRUZAFA S.L. (Hospital Arruzafa) Córdoba Spain Recruiting
Miranza Galicia Santiago de Compostela Spain Recruiting
Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM) Valencia Spain Recruiting
OBA - Universidad de Valladolid Valladolid Spain Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Recruiting

More Dompé Farmaceutici S.p.A trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07395232 on ClinicalTrials.gov ↗ ← All trials in the USA