Vernal KeratoconjunctivitisNCT02057822
Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months
An observational study of Vernal Keratoconjunctivitis and Healthy Children, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vernal Keratoconjunctivitis, Healthy Children
- What is being tested?
- Cytokins assay in tears
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jan 2016
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: healthy children children with vernal keratoconjunctivitis
Who may be able to join
- Childrens between 3 and 18 years
- Affiliated at system of French social security
- Signed by the holders of parental authority of the sheet and written consent to participate in this study
- First consultation at Clermont-Ferrand Hospital for vernal keratocunjunctivitis
Who cannot join
- Subject suffering from acute or chronic eye disease in which the physician investigator resound with the results: uveitis, glaucoma, retinopathy
- Subject who had undergone eye surgery
- Subject having an infection the day of collection: ENT, digestive, urinary
- Subject with cancer, mental illness or any other condition in which the physician investigator sound informed consent and / or the results
- Pregnant subject
- Subject with contact lenses
- Subject who judged by the investigating physician not enough cooperating to allow a safe collection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Cytokine Assay in Tears of Healthy Children and With Vernal Keratocunjonctivitis: Case Control Study and Monitoring of Cases at 6 Months
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.
Read the detailed description
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.
- Conditions
- Vernal Keratoconjunctivitis, Healthy Children
- Being tested
- Cytokins assay in tears
- Keywords
- Vernal keratoconjunctivitis, Cytokines, Mediators, Tears
- Medical subject headings
- Conjunctivitis, Allergic, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokins assay in tearsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| vernal keratoconjunctivitis | The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjonctivitis and in control subjects Receives: Procedure: Cytokins assay in tears | |
| healthy children | The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects Receives: Procedure: Cytokins assay in tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of 40 cytokines in tears
Comparaison of concentration of 40 cytokines in tears between healthy children and children with vernal keratoconjunctivitis
Measured: at time 0
Secondary outcomes (2)
Validation of normal range of cytokines in tears of healthy children
Measured: at 6 month
Modification of the inflammatory profile according to the clinical severity and treatment
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric CHIAMBARETTA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057822
- Sponsor's protocol ID
- CHU-0170
- Other IDs
- 2012-A00034-39
- Status last verified
- Feb 2014
- First submitted
- 25 Nov 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Assay in Tears of Healthy Children and With Vernal Keratocunjonctivitis: Case Control Study and Monitoring of Cases at 6 Months
- ClinicalTrials.gov ID
- NCT02057822
- Acronym / sponsor ID
- CHU-0170
- Conditions
- Vernal Keratoconjunctivitis, Healthy Children
- Keywords
- Vernal keratoconjunctivitis, Cytokines, Mediators, Tears
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 7 Feb 2014 (estimated)
- 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.
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.
Detailed description
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vernal keratoconjunctivitis | – | Procedure: Cytokins assay in tearsThe main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjonctivitis and in control subjects |
| healthy children | – | Procedure: Cytokins assay in tearsThe main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- healthy children children with vernal keratoconjunctivitis
Key inclusion criteria (4 listed)
- Childrens between 3 and 18 years
- Affiliated at system of French social security
- Signed by the holders of parental authority of the sheet and written consent to participate in this study
- First consultation at Clermont-Ferrand Hospital for vernal keratocunjunctivitis
Key exclusion criteria (7 listed)
- Subject suffering from acute or chronic eye disease in which the physician investigator resound with the results: uveitis, glaucoma, retinopathy
- Subject who had undergone eye surgery
- Subject having an infection the day of collection: ENT, digestive, urinary
- Subject with cancer, mental illness or any other condition in which the physician investigator sound informed consent and / or the results
- Pregnant subject
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 |
|---|---|---|
| Cytokins assay in tears | Procedure or surgery | healthy children, vernal keratoconjunctivitis |
Primary outcome
Concentration of 40 cytokines in tears
Time frame: at time 0
Comparaison of concentration of 40 cytokines in tears between healthy children and children with vernal keratoconjunctivitis
2 secondary outcomes
Validation of normal range of cytokines in tears of healthy children
Time frame: at 6 month
Modification of the inflammatory profile according to the clinical severity and treatment
Time frame: at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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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.
Frédéric CHIAMBARETTA principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vernal Keratoconjunctivitis and Healthy Children, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 7 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 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of 40 cytokines in tears (time frame: at time 0). 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 7 Feb 2014.