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

NCT02057822 | Unknown

• 2 other identifiers: CHU-01702012-A00034-39
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vernal Keratoconjunctivitis; Healthy Children

Keywords

Vernal keratoconjunctivitis; Cytokines; Mediators; Tears

Outcome Measures

Primary Outcomes (1)

• Concentration of 40 cytokines in tears

  Comparaison of concentration of 40 cytokines in tears between healthy children and children with vernal keratoconjunctivitis

  at time 0

Secondary Outcomes (2)

• Validation of normal range of cytokines in tears of healthy children

  at 6 month

• Modification of the inflammatory profile according to the clinical severity and treatment

  at 6 month

Study Arms (2)

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

Interventions

Cytokins assay in tears PROCEDURE

healthy children; vernal keratoconjunctivitis

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy children children with vernal keratoconjunctivitis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Allergic; Lacerations

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Wounds and Injuries

Study Officials

• Frédéric CHIAMBARETTA

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: February 7, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

FR (1)