An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
ConditionAtopic Keratoconjunctivitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-65
SponsorDompé Farmaceutici S.p.A
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Male or Female aged ≥ 10 and ≤ 65 years.
other atopic condition (ie., atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
Ocular itching of at least 50 as assessed by VAS scale.
Disqualifiers
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.
Evidence of an active ocular infection in either eye.
Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
Trial design
Design model
Parallel
Treatments tested in this trial
DFL24498
DrugDFL24498 will be instilled in each eye for 12 Weeks.
Vehicle
DrugVehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
dexamethasone sodium phosphate (DSP) ophthalmic solution
DrugRescue medication may be administered as required at the Investigator discretion.
Treatment groups
153 Participants
are divided into 2 treatment groupsGroup A: DFL24498Experimental treatment 2 interventions
Group B: VehiclePlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
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.
Time frame
Baseline and at Week 6Secondary outcomes
1
Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.
Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. Examination will be performed at the slit-lamp using blue (cobalt) light. Corneal fluorescein staining will be graded according to the modified Oxford scale (7-point scale: 0, 0.5. 1, 2, 3, 4, 5).
Time frame
Baseline and at Week 62
Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.
Bulbar conjunctival redness will be assessed at the slit-lamp examination using white light prior to vital dye instillation and graded according to the VBR 10 scale.
Time frame
Baseline and at Week 63
Change from baseline over time in ocular itching score assessed by VAS.
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.
Time frame
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 164
Change from baseline over time in ocular symptoms of itching, tearing, discomfort, mucous discharge, and photophobia on a 4-point scale (0 to 3).
Ocular symptoms are assessed using a 4-point severity scale ranging from 0 (none) to 3 (severe). Five ocular symptoms, itching, tearing, ocular discomfort (including burning, stinging, and foreign body sensation), mucous discharge, and photophobia are evaluated in the study eye. A composite symptom score is described in calculated at screening and Baseline by summing the individual symptom scores, resulting in a total score range of 0 to 15, with higher scores indicating greater symptom severity.
Time frame
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16Sponsors and contacts
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Source ClinicalTrials.gov