Actively Recruiting
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Led by Dompé Farmaceutici S.p.A · Updated on 2026-04-20
138
Participants Needed
19
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.
CONDITIONS
Official Title
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 65 years
- Diagnosis of AKC in both eyes with history of other atopic conditions such as atopic dermatitis, periocular eczema, asthma, or allergic rhinitis
- Chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis
- Ocular itching score of at least 50 on visual analog scale
- Corneal fluorescein staining of at least grade 1 and bulbar conjunctival hyperemia of at least 40 on VBR 10 scale in the same eye
- Composite symptoms score of 5 or higher based on itching, tearing, discomfort, photophobia, and mucous discharge
- For women of childbearing potential, negative pregnancy tests at screening and baseline, and use of acceptable contraception
You will not qualify if you...
- Inability to understand the local language to provide informed consent and complete assessments
- Active ocular infection in either eye
- Intraocular inflammation with anterior chamber flare above 0 by SUN grading
- Known or suspected ocular malignancy
- Presence of cancer or any unstable systemic disease affecting study participation
- Participants with only one functioning eye (anatomically monocular)
- Unstable systemic disease within 1 month before screening or conditions incompatible with frequent study assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 19 locations
1
Bowden Eye Associates - Southside Location
Jacksonville, Florida, United States, 32256
Actively Recruiting
2
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
3
Clayton Eye Clinical Research
Morrow, Georgia, United States, 30260
Actively Recruiting
4
Ophthalmology Associates
St Louis, Missouri, United States, 63131
Actively Recruiting
5
NYU Langone Health - Eye Center
New York, New York, United States, 10017
Actively Recruiting
6
Duke Eye Center - Ophthalmology
Durham, North Carolina, United States, 27710
Actively Recruiting
7
Total Eye Care, PA
Memphis, Tennessee, United States, 38119
Actively Recruiting
8
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology
Houston, Texas, United States, 77030
Actively Recruiting
9
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia
Bologna, Italy, 40138
Actively Recruiting
10
Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti
Chieti, Italy, 66100
Actively Recruiting
11
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
12
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy, 00128
Actively Recruiting
13
AOU Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
14
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37134
Actively Recruiting
15
METAVISION ARRUZAFA S.L. (Hospital Arruzafa)
Córdoba, Spain, 14012
Actively Recruiting
16
Miranza Galicia
Santiago de Compostela, Spain, 15706
Actively Recruiting
17
Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)
Valencia, Spain, 46015
Actively Recruiting
18
OBA - Universidad de Valladolid
Valladolid, Spain, 47011
Actively Recruiting
19
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
Research Team
D
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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