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

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

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

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between goblet cell density and the incidence of conjunctivitis over time | 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. | 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 | 
| Relationship between goblet cell density and the risk of conjunctivitis | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival changes during dupilumab treatment using Impression Cytology | Better understanding of conjunctival changes using Impression Cytology of the conjunctiva, collected at different time points during treatment with dupilumab in AD patients | baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment | 
| Optimal treatment of conjunctivitis | 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. | at the moment of the development of eye symptoms, 4 weeks after ocular treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupilumab, Dupixent, Conjunctivitis, Bioday