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DFL24498 for treating atopic keratoconjunctivitis (AKC)

A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Adult Participants With Atopic Keratoconjunctivitis (AKC)

Phase 3 Interventional Dompé Farmaceutici S.p.A · NCT07395232

This will test whether DFL24498 eye drops reduce inflammation and symptoms in adults aged 18–65 with chronic atopic keratoconjunctivitis compared with a vehicle eye drop.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment138 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorDompé Farmaceutici S.p.A Industry-sponsored
Locations19 sites (Jacksonville, Florida and 18 other locations)
Trial IDNCT07395232 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trial plans to enroll about 138 adults with bilateral AKC. After a screening period, participants are randomized to receive DFL24498 or vehicle ophthalmic solution and are treated through Week 12 with follow-up through Week 16. Key entry requirements include significant ocular itching, minimum corneal fluorescein staining and bulbar conjunctival hyperemia, and a minimum composite symptoms score. Efficacy and safety will be measured by symptom scales (including itch VAS and a composite symptom score), corneal staining, conjunctival hyperemia, and recording of adverse events.

Who should consider this trial

Good fit: Adults 18–65 with bilateral atopic keratoconjunctivitis, a history of atopic disease, ocular itching (VAS ≥50), corneal staining ≥ grade 1, bulbar conjunctival hyperemia ≥40, and a composite symptom score ≥5 are the intended participants.

Not a fit: Patients with mild or unilateral disease, those outside the 18–65 age range, pregnant women, or people who do not meet the specified sign and symptom thresholds are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, DFL24498 could provide a new topical option to reduce corneal and conjunctival inflammation and relieve itching for people with AKC.

How similar studies have performed: Topical corticosteroids and other anti-inflammatory eye drops are effective for AKC, but newer targeted ophthalmic agents like DFL24498 are relatively novel and have limited published late‑stage data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Jacksonville, Florida and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic Keratoconjunctivitischronic, recurrent ocular surface inflammation,DFL24498Ophthalmic solutionVehicle controlledEye drop solutionCorneal involvement
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.