Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
