Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411132
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögrens Dry Eye
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
A Multicenter Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögrens Dry Eye
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMINAE
Brief Summary:
Primary Objective
- To assess the proportion of patients with Sjögrens 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
- To assess the proportion of patients with Sjögrens 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
Detailed Description:
This clinical study has been designed to evaluate the proportion of patients with confirmed Sjögrens dry eye who present with neurosensory abnormalities via demonstration of increased ocular pain andor a decrease in corneal sensitivity
A multicenter design allows for a greater diversity of patient population with Sjögrens 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 Sjögrens 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
A multicenter design allows for a greater diversity of patient population with Sjögrens 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 Sjögrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None