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

Dompé

Status and phase: Enrolling; Phase 3

Conditions: Atopic Keratoconjunctivitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07395232

2025-522291-83-00 (EU Trial (CTIS) Number)

ICY-AKC-301

2025

Details and patient eligibility

About

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.

Full description

The study will consist of 3 periods:

1. Washout period (from Day -7 ± 1 to Day 1),
2. Treatment Period (from randomization through Week12) and
3. Follow-up period (Weeks 13 to 16).

Enrollment: 153 estimated patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 2 patient groups, including a placebo group

DFL24498

Experimental group

Description:

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

Treatment:

Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution

Drug: DFL24498

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution