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

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ClinicalTrials.gov Identifier: NCT03358979
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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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.

Condition or disease
Conjunctival Diseases Dry Eye Syndromes

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024
Groups and Cohorts
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Group/Cohort
Severe eye dryness
absence of eye dryness


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe eye dryness will be compared with persons without eye dryness.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358979


Contacts
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Contact: Amélie YAVCHITZ 01.48.03.64.33 ext +33 ayvachitz@for.paris

Locations
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France
Fondation Ophtalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Eric GABISON       egabison@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Eric GABISON Fondation Ophtalmologique A. de Rothschild
More Information
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03358979    
Other Study ID Numbers: EGN_2017_15
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Conjunctival Diseases
Dry Eye Syndromes
Antigens
CD147
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Syndrome
Disease
Pathologic Processes
 Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Keratitis
Corneal Diseases