DFL24498: DFL24498 will be instilled in each eye for 12 Weeks.
Vehicle: Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
dexamethasone sodium phosphate (DSP) ophthalmic solution: Rescue medication may be administered as required at the Investigator discretion.
Study summary
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. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.
Eligibility
Sex
ALL
Min age
10 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS). — Baseline and at Week 6 The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Trial sites (19)
Facility
City
Region
Status
Bowden Eye Associates - Southside Location
Jacksonville
Florida
Recruiting
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
Miami
Florida
Recruiting
Clayton Eye Clinical Research
Morrow
Georgia
Recruiting
Ophthalmology Associates
St Louis
Missouri
Recruiting
NYU Langone Health - Eye Center
New York
New York
Recruiting
Duke Eye Center - Ophthalmology
Durham
North Carolina
Recruiting
Total Eye Care, PA
Memphis
Tennessee
Recruiting
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology
Houston
Texas
Recruiting
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia
Bologna
Italy
Recruiting
Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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