TrialPath
← Back to searchRecruiting

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

NCT07395232 · Dompé Farmaceutici S.p.A
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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)
About this study
The study will consist of 3 periods: 1. Screening period (from Day -7 ± 1 to Day 1), 2. Treatment Period (from randomization through Week12) and 3. Follow-up period (Weeks 13 to 16).
Eligibility 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
Study design
Enrollment target: 138 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-01
Estimated completion: 2027-05
Last updated: 2026-02-09
Interventions
Drug: DFL24498Drug: VehicleDrug: dexamethasone sodium phosphate (DSP) ophthalmic solution
Primary outcomes
  • Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS). (Baseline and at Week 6)
Sponsor
Dompé Farmaceutici S.p.A · industry
Contacts & investigators
ContactDompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) · contact · +39 02 583 831
All locations (19)
Bowden Eye Associates - Southside LocationRecruiting
Jacksonville, Florida, United States
University of Miami, Miller School of Medicine, Bascom Palmer Eye InstituteNot Yet Recruiting
Miami, Florida, United States
Clayton Eye Clinical ResearchRecruiting
Morrow, Georgia, United States
Ophthalmology AssociatesRecruiting
St Louis, Missouri, United States
NYU Langone Health - Eye CenterNot Yet Recruiting
New York, New York, United States
Duke Eye Center - OphthalmologyNot Yet Recruiting
Durham, North Carolina, United States
Total Eye Care, PARecruiting
Memphis, Tennessee, United States
Baylor University Jamail Specialty Care Center- Alkek Eye Center- OphthalmologyNot Yet Recruiting
Houston, Texas, United States
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO OftalmologiaNot Yet Recruiting
Bologna, Italy
Ospedale SS Annunziata, ASL 2 Lanciano Vasto ChietiNot Yet Recruiting
Chieti, Italy
Azienda Ospedaliero Universitaria CareggiNot Yet Recruiting
Florence, Italy
Fondazione Policlinico Universitario Campus Bio-MedicoNot Yet Recruiting
Roma, Italy
AOU Policlinico Umberto INot Yet Recruiting
Roma, Italy
Azienda Ospedaliera Universitaria Integrata VeronaNot Yet Recruiting
Verona, Italy
METAVISION ARRUZAFA S.L. (Hospital Arruzafa)Recruiting
Córdoba, Spain
Miranza GaliciaRecruiting
Santiago de Compostela, Spain
Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)Recruiting
Valencia, Spain
OBA - Universidad de ValladolidNot Yet Recruiting
Valladolid, Spain
Hospital Universitario Miguel ServetNot Yet Recruiting
Zaragoza, Spain
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC · TrialPath