Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE) (ALTESSE)

Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes; Conjunctival Diseases

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Amélie YAVCHITZ; Phone Number: +33 01.48.03.64.33; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Fondation Ophtalmologique A de Rothschild
    • Contact: Eric GABISON; Email: egabison@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe eye dryness will be compared with persons without eye dryness.

Description

Patients:

Inclusion criteria

• 18 years and over
• Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop (2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, Tear Break Up Time ≤ 5 seconds (fluorescein test) Schirmer's test score without anesthesia ≤ 5mm at 5 minutes

Exclusion criteria

• Treatment with topical ciclosporin
• Autologous serum treatment
• Wearer of scleral lenses
• Known pregnancy or breastfeeding

Control subjects:

Inclusion criteria

• 18 years and over
• Tear Break Up Time > 5 seconds (fluorescein test)

Exclusion criteria

• Wearer of contact lenses
• Functional ocular signs
• Anomalies of the ocular surface observed during examination with the slit lamp
• Fluorescein staining of the ocular surface (cornea, conjunctiva)
• Topical ocular treatment
• Known pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Severe eye dryness
absence of eye dryness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of surface area of cell markers measured on conjunctival epithelial cells, in persons with and without severe eye dryness.	Comparison of the mean surface in patients before treatment for eye dryness versus in persons with no eye dryness. Immunofluorescence analysed in confocal microscopy on conjunctival impression cytology.	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Eric GABISON, Fondation Ophtalmologique A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Antigens; Conjunctival Diseases; Dry Eye Syndromes; CD147
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctival Diseases
• Other Study ID Numbers: EGN_2017_15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No