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

NCT07395232 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: ICY-AKC-3012025-522291-83-00
• Study Type: interventional
• Target: 138
• Locations: 3 countries
• Sites: 19

Brief 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.

Conditions

Atopic Keratoconjunctivitis

Keywords

chronic, recurrent ocular surface inflammation,; Atopic Keratoconjunctivitis; DFL24498; Ophthalmic solution; Vehicle controlled; Eye drop solution; Corneal involvement

Outcome Measures

Primary Outcomes (1)

• Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).

  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.

  Baseline and at Week 6

Secondary Outcomes (16)

• Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.

  Baseline and at Week 6

• Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.

  Baseline and at Week 6

• Change from baseline over time in ocular itching score assessed by VAS.

  Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16

• Change from baseline over time in ocular symptoms of itching, tearing, discomfort, mucous discharge, and photophobia on a 4-point scale (0 to 3).

  Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16

• Change from baseline over time in corneal fluorescein staining (modified Oxford scale) in the study eye.

  Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16

Study Arms (2)

DFL24498

EXPERIMENTAL

Participants will be administered with DFL24498 eye drops in both eyes.

Drug: DFL24498; Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution

Vehicle

PLACEBO COMPARATOR

Participants will be administered with vehicle eye drops in both eyes.

Drug: Vehicle; Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution

Interventions

DFL24498 DRUG

DFL24498 will be instilled in each eye for 12 Weeks.

DFL24498

Vehicle DRUG

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

Vehicle

dexamethasone sodium phosphate (DSP) ophthalmic solution DRUG

Rescue medication may be administered as required at the Investigator discretion.

DFL24498; Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Men or women aged ≥ 18 and ≤ 65 years of age.
• Diagnosis of AKC in both eyes, including the presence or medical history of the following:
• other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
• chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
• Ocular itching of at least 50 as assessed by VAS scale.
• 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.
• 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).
• 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.

You may not qualify if:

• Participants will be excluded if any of the following criteria apply:
• 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.
• Evidence of an active ocular infection in either eye.
• Intraocular inflammation defined as anterior chamber flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
• Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
• 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.
• Participants that are anatomically monocular.
• 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.

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (19)

Bowden Eye Associates - Southside Location

Jacksonville, Florida, 32256, United States

RECRUITING

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

Miami, Florida, 33136, United States

RECRUITING

Clayton Eye Clinical Research

Morrow, Georgia, 30260, United States

RECRUITING

Ophthalmology Associates

St Louis, Missouri, 63131, United States

RECRUITING

NYU Langone Health - Eye Center

New York, New York, 10017, United States

RECRUITING

Duke Eye Center - Ophthalmology

Durham, North Carolina, 27710, United States

RECRUITING

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia

Bologna, 40138, Italy

RECRUITING

Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti

Chieti, 66100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

RECRUITING

AOU Policlinico Umberto I

Roma, 00161, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37134, Italy

RECRUITING

METAVISION ARRUZAFA S.L. (Hospital Arruzafa)

Córdoba, 14012, Spain

RECRUITING

Miranza Galicia

Santiago de Compostela, 15706, Spain

RECRUITING

Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)

Valencia, 46015, Spain

RECRUITING

OBA - Universidad de Valladolid

Valladolid, 47011, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

dexamethasone 21-phosphate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

CONTACT

+39 02 583 831

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 9, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); IT (6); ES (5)