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NCT Number: NCT03358979

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Eric GABISON

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

- Known pregnancy or breastfeeding

Control subjects:

Inclusion criteria

  • 18 years and over

Exclusion criteria

  • Wearer of contact lenses
  • Topical ocular treatment
  • Known pregnancy or breastfeeding

Treatment and study plan

Primary outcomes

  1. comparison of surface area of cell markers measured on conjunctival epithelial cells, in persons with and without severe eye dryness.

    Time frame: baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie YAVCHITZ

CONTACT

[email protected]

01.48.03.64.33 ext. +33

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: ALTESSE

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Dec 2, 2017
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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