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Recruiting Phase 3 NCT07395232

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

Phase 3 – large-scale trial before approval
Conditions: Atopic Keratoconjunctivitis

Sponsor: Dompé Farmaceutici S.p.A

trial.available_in: БГ
Overview
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.
Description
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).
Who can participate
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
Interventions
DFL24498
DRUG
Vehicle
DRUG
dexamethasone sodium phosphate (DSP) ophthalmic solution
DRUG
Locations 19
Italy (6)
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia
Bologna
Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti
Chieti
Azienda Ospedaliero Universitaria Careggi
Florence
Fondazione Policlinico Universitario Campus Bio-Medico
Roma
AOU Policlinico Umberto I
Roma
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Spain (5)
METAVISION ARRUZAFA S.L. (Hospital Arruzafa)
Córdoba
Miranza Galicia
Santiago de Compostela
Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)
Valencia
OBA - Universidad de Valladolid
Valladolid
Hospital Universitario Miguel Servet
Zaragoza
United States (8)
Duke Eye Center - Ophthalmology
Durham , North Carolina
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology
Houston , Texas
Bowden Eye Associates - Southside Location
Jacksonville , Florida
Total Eye Care, PA
Memphis , Tennessee
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
Miami , Florida
Clayton Eye Clinical Research
Morrow , Georgia
NYU Langone Health - Eye Center
New York , New York
Ophthalmology Associates
St Louis , Missouri
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.12.2025
Completion date
01.05.2027
Registry ID
NCT07395232
Source
clinicaltrials.gov
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