Conjunctival DiseasesCYCLADDENCT04066998
Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
A study testing Tears sampling and Lashes sampling in people with Conjunctival Diseases and Atopic Dermatitis, run by Centre Hospitalier Universitaire de Besancon.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctival Diseases, Atopic Dermatitis, Side Effect
- What is being tested?
- Tears sampling and Lashes sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab
- Conditions
- Conjunctival Diseases, Atopic Dermatitis, Side Effect
- Being tested
- Tears sampling, Lashes sampling
- Medical subject headings
- Conjunctival Diseases, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tears samplingOther
Tears sampling
Lashes samplingOther
Lashes sampling
| Study group | Role | What they receive |
|---|---|---|
| Conjunctivitis | Experimental | Patients treated with Dupilumab with conjunctivitis Receives: Other: Tears sampling; Other: Lashes sampling |
| No conjunctivitis | Other | Patients treated with Dupilumab and showing no signs of ocular involvement Receives: Other: Tears sampling; Other: Lashes sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 8
Secondary outcomes (4)
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.
Measured: Month 8
Absence/Presence of demodex
Presence of demodex on lashes before treatment with Dupilumab
Measured: Day 0
Increase of lacrimal eosinophiles
Measured: 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)
Measured: Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study startDec 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctival DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille FEBVAY, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066998
- Sponsor's protocol ID
- P/2019/424
- Acronym
- CYCLADDE
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
- ClinicalTrials.gov ID
- NCT04066998
- Acronym / sponsor ID
- CYCLADDE / P/2019/424
- Conditions
- Conjunctival Diseases, Atopic Dermatitis, Side Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conjunctivitis | Experimental | Other: Tears sampling, Other: Lashes samplingPatients treated with Dupilumab with conjunctivitis |
| No conjunctivitis | Other | Other: Tears sampling, Other: Lashes samplingPatients treated with Dupilumab and showing no signs of ocular involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tears samplingTears sampling | Other | Conjunctivitis, No conjunctivitis |
| Lashes samplingLashes sampling | Other | Conjunctivitis, No conjunctivitis |
Primary outcome
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.
4 secondary outcomes
Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups
Time frame: Month 8
Absence/Presence of demodex
Time frame: Day 0
Increase of lacrimal eosinophiles
Time frame: Month 8
Improvement of quality of life
Time frame: Month 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille FEBVAY, MD principal investigator
CHU de Besançon
Questions about this trial
What is this clinical trial studying?
A study testing Tears sampling and Lashes sampling in people with Conjunctival Diseases and Atopic Dermatitis, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise VUILLEMEY, Int (033381669454, louise.vuillemey@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of lacrimal inflammatory cytokines (time frame: Month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.