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

November 15, 2019 updated by: Centre Hospitalier Universitaire de Besancon
This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Conjunctivitis
Patients treated with Dupilumab with conjunctivitis
Other: Tears sampling
Tears sampling
Other: Lashes sampling
Lashes sampling
OTHER: No conjunctivitis
Patients treated with Dupilumab and showing no signs of ocular involvement
Other: Tears sampling
Tears sampling
Other: Lashes sampling
Lashes sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of lacrimal inflammatory cytokines
Time Frame: 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.
Month 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Camille FEBVAY, MD, CHU de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2019

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (ACTUAL)

August 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2019/424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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