Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab

Study Overview
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Brief Summary
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This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab

Official Title
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Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab

Conditions
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Conjunctival Diseases, Atopic Dermatitis, Side Effect

Intervention / Treatment
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* Other: Tears sampling
* Other: Lashes sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with severe atopic dermatitis resistant to main immunosuppressive drugs treated with Dupilumab with or without conjunctivitis postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception Exclusion Criteria: - pregnant or breastfeeding women

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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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conjunctivitis<br>Patients treated with Dupilumab with conjunctivitis | Other: Tears sampling<br>* Tears sampling<br>Other: Lashes sampling<br>* Lashes sampling<br>|
| Other: No conjunctivitis<br>Patients treated with Dupilumab and showing no signs of ocular involvement | Other: Tears sampling<br>* Tears sampling<br>Other: Lashes sampling<br>* Lashes sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of lacrimal inflammatory cytokines | Change in inflammatory cytokines in tears collected by capillary before and after treatment with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α. | Month 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups | Change in inflammatory cytokines in tears collected by capillary among conjunctivitis patients versus non conjunctivitis patients, when treated with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α. | Month 8 | 
| Absence/Presence of demodex | Presence of demodex on lashes before treatment with Dupilumab | Day 0 | 
| Increase of lacrimal eosinophiles |  | Month 8 | 
| Improvement of quality of life | Improvement of quality of life for patients treated with Dupilumab, assessed with Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 (normal/no ocular involvement) to 100 (severe ocular disease) | Month 8 |