An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
ConditionAtopic Keratoconjunctivitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
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. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.
Eligibility criteria
Qualifiers
Men or women aged ≥ 18 and ≤ 65 years of age.
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
Treatments tested in this trial
- DFL24498
- Vehicle
- dexamethasone sodium phosphate (DSP) ophthalmic solution
Treatment groups
138 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov