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Clinical Trial Summary

Primary Objective - To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity. Secondary Objectives - To assess corneal sensitivity via Cochet-Bonnet esthesiometer. - To assess tear secretion via Schirmer I test. - To assess OPAS questionnaire results.


Clinical Trial Description

This clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who present with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity. A multicenter design allows for a greater diversity of patient population with Sjögren's dry eye. The number of sites allows for quick enrollment and expedited results that will help physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye. This study design is minimally invasive and may be completed in a single visit provided all qualification criteria are met. This design reduces the time commitment from patients, thereby reducing barriers for enrollment and participation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06411132
Study type Observational
Source Dompé Farmaceutici S.p.A
Contact Marta Sacchetti, MD, PhD
Phone +39 02 583831
Email clinical.trials@dompe.com
Status Recruiting
Phase
Start date March 15, 2024
Completion date February 3, 2025

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