Actively Recruiting
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)
Led by Dompé Farmaceutici S.p.A · Updated on 2026-04-20
138
Participants Needed
19
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of DFL24498 eye drops compared with a placebo solution in adults with Atopic Keratoconjunctivitis (AKC), a condition involving inflammation and itching of the eyes. This phase 3, multicenter, randomized, double-masked study will include approximately 138 participants who meet specific criteria. The trial is sponsored by Dompé Farmaceutici S.p.A and aims to provide detailed information about this treatment for AKC. The study has three main periods: a screening period lasting up to one week before treatment, a 12-week treatment period where participants receive either DFL24498 or vehicle eye drops in both eyes, and a follow-up period lasting from week 13 to week 16. Rescue medication with dexamethasone sodium phosphate ophthalmic solution may be given if needed. The trial uses a randomized and triple-masked design to compare the study drug against a placebo. Participants will undergo various assessments including ocular itching scores, corneal staining, conjunctival redness, and other eye condition signs at multiple points during the study. Quality of life and patient-reported changes will also be measured. Safety will be monitored through adverse event reporting and visual acuity tests. The total participation duration spans from screening through the follow-up period, about 16 weeks in all.
CONDITIONS
Brief 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 Atopic Keratoconjunctivitis (AKC) in both eyes
- Presence or 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 the visual analog scale
- Corneal fluorescein staining of at least grade 1 and bulbar conjunctival hyperemia of at least 40 on the validated scale in the same eye
- Composite symptoms score of 5 or higher based on itching, tearing, discomfort, photophobia, and mucous discharge
- Negative pregnancy test at screening and baseline and use of acceptable contraception if a woman of childbearing potential
You will not qualify if you...
- Inability to understand the local language well enough to provide informed consent and complete assessments
- Active ocular infection in either eye
- Intraocular inflammation with anterior chamber flare greater than 0
- Known or suspected ocular malignancy
- Presence of cancer or unstable systemic disease that may interfere with participation
- Participants with only one functioning eye
- Systemic diseases not stabilized within one month before screening or conditions incompatible with frequent study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 week
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants will receive DFL24498 or vehicle eye drops in both eyes for up to 12 weeks to evaluate efficacy and safety.
Visits at baseline, Week 4, Week 6, Week 8, and Week 12
Duration - 4 weeks
Participants are monitored for safety and ongoing outcomes after the treatment period ends.
Visits at Week 16
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)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here