Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057822
Recruitment Status : Unknown
Verified February 2014 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.

Condition or disease Intervention/treatment
Vernal Keratoconjunctivitis Healthy Children Procedure: Cytokins assay in tears

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Cytokine Assay in Tears of Healthy Children and With Vernal Keratocunjonctivitis: Case Control Study and Monitoring of Cases at 6 Months
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Validation of normal range of cytokines in tears of healthy children [ Time Frame: at 6 month ]
  2. Modification of the inflammatory profile according to the clinical severity and treatment [ Time Frame: at 6 month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy children children with vernal keratoconjunctivitis
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057822


Contacts
Layout table for location contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Frédéric CHIAMBARETTA University Hospital, Clermont-Ferrand
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02057822    
Other Study ID Numbers: CHU-0170
2012-A00034-39
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by University Hospital, Clermont-Ferrand:
Vernal keratoconjunctivitis
Cytokines
Mediators
Tears
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
 Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases