Analysis of cell surface markers in severe dry eye syndrome
Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)
This study looks at changes in certain markers on eye cells in people with severe dry eye syndrome to see how they change before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT03358979 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the changes in cell surface markers, specifically EMMPRIN, on conjunctival epithelial cells in patients with severe dry eye syndrome. It aims to describe the distribution of these markers before and after treatment initiation. The study includes patients with severe eye dryness and control subjects with normal tear break up times, allowing for a comparative analysis of the epithelial cell surface modifications. The findings could provide insights into the pathophysiology of dry eye syndrome and potential treatment responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with severe dry eye symptoms as defined by specific clinical criteria.
Not a fit: Patients currently using topical ciclosporin, autologous serum treatment, or wearing scleral lenses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of dry eye syndrome and lead to improved treatment strategies for patients.
How similar studies have performed: While this study focuses on a specific marker in dry eye syndrome, similar studies have shown promise in understanding ocular surface diseases, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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 * Patients without eye treatment or patients undergoing long-term stable eye treatment for whom a new treatment is being introduced Exclusion criteria - Known pregnancy or breastfeeding Control subjects: Inclusion criteria \- 18 years and over Exclusion criteria * Wearer of contact lenses * Topical ocular treatment * Known pregnancy or breastfeeding
Where this trial is running
Paris
- Fondation Ophtalmologique A de Rothschild — Paris, France (Recruiting)
Study contacts
- Principal investigator: Eric GABISON — Fondation Ophtalmologique A. de Rothschild
- Study coordinator: Amélie YAVCHITZ
- Email: ayavchitz@for.paris
- Phone: 01.48.03.64.33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.