Recruiting
Phase 3

DFL24498

Sponsor:

Dompé Farmaceutici S.p.A

Code:

NCT07395232

Conditions

Atopic Keratoconjunctivitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

DFL24498

Vehicle

dexamethasone sodium phosphate (DSP) ophthalmic solution

Study Details

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

Study ID

NCT07395232

Start date

Dec 1, 2025

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DFL24498

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

placebo comparator: Vehicle

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

Interventions

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.

Primary outcome measure

  • Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS). [ Time Frame: Baseline and at Week 6 ]

Central Contacts and Locations

Central contacts

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

+39 02 583 831

Locations

Bowden Eye Associates - Southside Location

Recruiting

Jacksonville, Florida, United States, 32256

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

Recruiting

Miami, Florida, United States, 33136

Clayton Eye Clinical Research

Recruiting

Morrow, Georgia, United States, 30260

Ophthalmology Associates

Recruiting

St Louis, Missouri, United States, 63131

NYU Langone Health - Eye Center

Recruiting

New York, New York, United States, 10017

Duke Eye Center - Ophthalmology

Recruiting

Durham, North Carolina, United States, 27710

Total Eye Care, PA

Recruiting

Memphis, Tennessee, United States, 38119

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

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Dompé Farmaceutici S.p.A

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dompé Farmaceutici S.p.A on 2026-04-20.