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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03358979
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 74.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	Intervention/Treatment	Phase
Conjunctival Diseases; Dry Eye Syndromes

Study Design

• Study Type: Observational
• Anticipated 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: Dec 14, 2017
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Severe eye dryness
absence of eye dryness

Outcome Measures

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique A de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03358979
• Other Study ID Numbers: EGN_2017_15
• First Posted: Dec 2, 2017
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• 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: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctival Diseases; Syndrome

Study Results

No Results Posted as of Jan 21, 2022