NCT06411132

Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye

A Multicenter, Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Ocular Pain Assessment Survey (OPAS) questionnaire results.

Detailed description

This observational clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who presented with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity. A multicenter design allowed for a greater diversity of patient population with Sjögren's dry eye. The number of sites allowed for quick enrollment and expedited results that helped physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye. This study design was minimally invasive and might be completed in a single visit provided all qualification criteria were met. This design reduced the time commitment from patients, thereby reducing barriers for enrollment and participation. Only one eye (study eye) was analyzed for endpoints; if both eyes qualified for the study, the eye with the worse staining (per National Eye Institute \[NEI\] scale) was the study eye. If staining was equal between eyes, the right eye was the study eye. Please note that no safety monitoring was captured, as this was an observational and descriptive study, and no study drug was administered. All testing and procedures conducted in this study were performed consistent with clinical practice standards and should not pose any additional risk to patients.

Conditions

• Sjögren Syndrome
• Dry Eye

Interventions

Type	Name	Description
OTHER	observational study	observational study

Timeline

• Start date: 2024-05-09
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2024-05-13
• Last updated: 2025-11-20

Locations

15 sites across 1 country: United States