The primary objective of the study is to characterize the clinical phenotype(s) of DUPIXENT®-associated conjunctivitis events.
The secondary objectives of the study are to characterize the course of conjunctivitis events during the observation period and collect and assess data on treatment for conjunctivitis events and its effectiveness.
Condition or Disease
This is a parallel-group, double-blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.
|Estimated Enrollment:||75 participants|
|Official Title:||Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis|
|Actual Study Start Date:||March 10, 2021|
|Estimated Primary Completion Date:||December 13, 2022|
|Estimated Study Completion Date:||December 13, 2022|
Primary Outcome Measures
- Baseline Ophthalmologist Diagnosis [ Time Frame: Initial Visit (Day 1) ]
- Diagnosis includes: symptoms and morphological features of conjunctivitis
- Proportion of patients in each category of ophthalmologist diagnoses [ Time Frame: Initial Visit (Day 1) ]
- Symptoms / Morphological features
- Proportion of patients with symptoms [ Time Frame: Initial Visit (Day 1) up to week 52 ]
- Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc
- Proportion of patients with morphological features [ Time Frame: Initial Visit (Day 1) up to week 52 ]
- Morphological features include but are not limited to: bulbar redness, limbal redness, lid redness, lid roughness, etc. and associated conditions may include blepharitis, keratitis, etc.
- Proportion of conjunctivitis events by severity [ Time Frame: Initial Visit (Day 1) up to week 52 ]
- Severity is based on the nature of the event, intensity of signs and/or symptoms, current functional impairment, and potential long-term health hazards related to the event. 3-point scale: Mild, Moderate or Severe.
- Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved [ Time Frame: Up to week 52 ]
- Proportion of patients with conjunctivitis event resolution [ Time Frame: Up to week 52 ]
- Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events [ Time Frame: Up to week 52 ]
- Ophthalmologists assessment of treatment effectiveness, overall and by clinical phenotype based on a 5-point scale. [ Time Frame: Up to week 52 ]
Treatment Effectiveness assessed on a 5-point scale: Poor, Fair, Good, Very Good, Excellent
- Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue [ Time Frame: Up to week 52 or resolution ]
Measured by conjunctival impression sample (EyeprimTM) for cytology and RNA sequencing
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Treatment with DUPIXENT® for AD (per the current US Prescribing Information) should be ongoing, and have been initiated at least 8 weeks prior to study enrollment. NOTE: A single missed dose in the 8 weeks prior to enrollment is allowed.
- Patients with protocol-specified conjunctivitis events must present with active bilateral conjunctivitis (with or without cornea or eyelid involvement) diagnosed by the ophthalmologist (investigator) which meets all of the following criteria:
- Developed (or significantly worsened) while receiving treatment with DUPIXENT® for AD
- Is clinically significant (eg, moderate-to-severe, extensive, persistent, etc) as determined by the investigator
- There is a suspected causal relationship between DUPIXENT® and conjunctivitis because:
- Conjunctivitis is a new-onset condition or an unusual worsening of a preexisting condition (eg, significantly more severe, more extensive, or more protracted than ever before) AND
- No alternative explanation is more plausible, in the opinion of the investigator
- Reference patients must have AD treated with current ongoing treatment with DUPIXENT® for equal or longer duration as compared to group 1, with no clinical signs of ocular inflammation noted during the entire DUPIXENT® treatment
- Any known medical, social, or personal limitations that are likely to restrict the patient’s ability to undergo study visits and complete study procedures (as assessed by the investigator), including hypersensitivity or other contraindications to the anesthetic eye drops used during the ophthalmological examination.