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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known pregnancy or breastfeeding

Wearer of contact lenses

Topical ocular treatment

Known pregnancy or breastfeeding

Trial population

Patients with severe eye dryness will be compared with persons without eye dryness.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Severe eye dryness
Group B: absence of eye dryness

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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