Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03358979
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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

Layout table for study information
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 : April 2019
Estimated Study Completion Date : April 2019

Group/Cohort
Severe eye dryness
absence of eye dryness



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
Contact: Laurence SALOMON 01.48.03.64.31 ext +33 lsalomon@for.paris

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Eric GABISON Fondation Ophtalmologique A. de Rothschild

Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03358979     History of Changes
Other Study ID Numbers: EGN_2017_15
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Layout table for additional information
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:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Syndrome
Conjunctival Diseases
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases