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

Healthy Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02057822
• Other study ID #: CHU-0170
• Secondary ID: 2012-A00034-39
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2013
• Last updated: February 6, 2014
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Healthy Children
• Keratoconjunctivitis
• Vernal Keratoconjunctivitis

Intervention

Procedure:
• Cytokins assay in tears

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Bruno PEREIRA, Delegation of Clinical Research & Innovation, Clermont-Ferrand Hospital, Dr Jean luc FAUQUERT, Departement of Pediatry, Clermont-Ferrand Hospital, Olivier BONS, Department of Ophthalmology, Clermont-Ferrand Hospital, Pr Frédéric CHIAMBARETTA, Department of Ophthalmology, Clermont-Ferrand Hospital, Pr Vincent SAPIN, Departement of Biology, Clermont-Ferrand Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Validation of normal range of cytokines in tears of healthy children		at 6 month	Yes
Secondary	Modification of the inflammatory profile according to the clinical severity and treatment		at 6 month	Yes