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

Not Applicable

• Conditions: Conjunctival Diseases; Atopic Dermatitis; Side Effect
• Interventions: Other: Tears sampling; Other: Lashes sampling

• Registration Number: NCT04066998
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Study Start: 2019-12
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No conjunctivitis	Tears sampling	Patients treated with Dupilumab and showing no signs of ocular involvement
Conjunctivitis	Lashes sampling	Patients treated with Dupilumab with conjunctivitis
Conjunctivitis	Tears sampling	Patients treated with Dupilumab with conjunctivitis
No conjunctivitis	Lashes sampling	Patients treated with Dupilumab and showing no signs of ocular involvement

Primary Outcome Measures

Name	Time	Method
Increase of lacrimal inflammatory cytokines	Month 8	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups	Month 8	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.
Absence/Presence of demodex	Day 0	Presence of demodex on lashes before treatment with Dupilumab
Increase of lacrimal eosinophiles	Month 8
Improvement of quality of life	Month 8	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)