Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment

Overview

Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Clinical Trial Outcome Measures

Primary Measures

  • Relationship between goblet cell density and the incidence of conjunctivitis over time
    • Time Frame: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
    • Establish the relationship between goblet cell densitiy and the incidence of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.
  • Relationship between goblet cell density and the risk of conjunctivitis
    • Time Frame: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
    • Establish the relationship between goblet cell densitiy and the risk of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.

Secondary Measures

  • Conjunctival changes during dupilumab treatment using Impression Cytology
    • Time Frame: baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
    • Better understanding of conjunctival changes using Impression Cytology of the conjunctiva, collected at different time points during treatment with dupilumab in AD patients
  • Optimal treatment of conjunctivitis
    • Time Frame: at the moment of the development of eye symptoms, 4 weeks after ocular treatment
    • Establish the most optimal treatment of conjunctivitis during dupilumab treatment. Ophthalmological examination will be compared at all time points to determine if the prescribed therapy is effective and optimal.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment . Exclusion Criteria:

  • Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UMC Utrecht
  • Collaborator
    • Sanofi
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr M.S. de Bruin-Weller, Principle Investigator – UMC Utrecht
  • Overall Contact(s)
    • Roselie Achten, MD, 0031 88 75 57439, r.e.achten@umcutrecht.nl

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