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NCT07395232PHASE3Recruiting

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

Dompé Farmaceutici S.p.A

Start Date

12/1/2025

Completion Date

5/1/2027

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.

Detailed Description

The study will consist of 3 periods: 1. Screening period (from Day -7 ± 1 to Day 1), 2. Treatment Period (from randomization through Week12) and 3. Follow-up period (Weeks 13 to 16).

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Men or women aged ≥ 18 and ≤ 65 years of age. 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

Interventions

DRUG

DFL24498

DRUG

Vehicle

DRUG

dexamethasone sodium phosphate (DSP) ophthalmic solution

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Atopic Keratoconjunctivitis

Locations

Bowden Eye Associates - Southside Location

Jacksonville, Florida 32256

United States

University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute

Miami, Florida 33136

United States

Clayton Eye Clinical Research

Morrow, Georgia 30260

United States

Ophthalmology Associates

St Louis, Missouri 63131

United States

NYU Langone Health - Eye Center

New York, New York 10017

United States

Duke Eye Center - Ophthalmology

Durham, North Carolina 27710

United States

Total Eye Care, PA

Memphis, Tennessee 38119

United States

Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology

Houston, Texas 77030

United States

IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia

Bologna, 40138

Italy

Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti

Chieti, 66100

Italy

Azienda Ospedaliero Universitaria Careggi

Florence, 50134

Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128

Italy

AOU Policlinico Umberto I

Roma, 00161

Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37134

Italy

METAVISION ARRUZAFA S.L. (Hospital Arruzafa)

Córdoba, 14012

Spain

Miranza Galicia

Santiago de Compostela, 15706

Spain

Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)

Valencia, 46015

Spain

OBA - Universidad de Valladolid

Valladolid, 47011

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain