Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months

February 6, 2014 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

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

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy children children with vernal keratoconjunctivitis

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vernal keratoconjunctivitis
The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjonctivitis and in control subjects
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
Procedure: Cytokins assay in tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at time 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Validation of normal range of cytokines in tears of healthy children
Time Frame: at 6 month
at 6 month
Modification of the inflammatory profile according to the clinical severity and treatment
Time Frame: at 6 month
at 6 month

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Frederic CHIAMBARETTA, University Hospital, Clermont-Ferrand

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

November 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0170
  • 2012-A00034-39

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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