Dry Eye Syndromes Clinical Trial
— ALTESSEOfficial title:
Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)
NCT number | NCT03358979 |
Other study ID # | EGN_2017_15 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 14, 2017 |
Est. completion date | March 2026 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique A de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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