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

NCT03358979 | Recruiting

• 1 other identifier: EGN_2017_15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Conjunctival Diseases; Dry Eye Syndromes

Keywords

Conjunctival Diseases; Dry Eye Syndromes; Antigens; CD147

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Severe eye dryness

absence of eye dryness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Patients without eye treatment or patients undergoing long-term stable eye treatment for whom a new treatment is being introduced

You may not qualify if:

• Control subjects:
• \- 18 years and over
• Wearer of contact lenses
• Topical ocular treatment
• Known pregnancy or breastfeeding

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Conjunctival Diseases; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Eric GABISON

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie YAVCHITZ

CONTACT

01.48.03.64.33; ayavchitz@for.paris

Study Design

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

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: December 14, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (1)