DFL24498 for treating atopic keratoconjunctivitis (AKC)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Bowden Eye Associates - Southside Location
  Jacksonville, Florida, United States Recruiting
• University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
  Miami, Florida, United States Recruiting
• Clayton Eye Clinical Research
  Morrow, Georgia, United States Recruiting
• Ophthalmology Associates
  St Louis, Missouri, United States Recruiting
• NYU Langone Health - Eye Center
  New York, New York, United States Recruiting
• Duke Eye Center - Ophthalmology
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
• Phone: +39 02 583 831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.