Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT06411132
Status:
TERMINATED
Last Update Posted:
2025-11-20
First Post:
2024-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Sponsor:
Dompé Farmaceutici S.p.A
Organization:
Study Overview
Official Title:
A Multicenter, Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The analyses presented are based on a database lock date of 05 March 2025.The study was prematurely interrupted by Dompé following a review of the database, which determined that an acceptable no. of patients was reached to meet the trial objectives.
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 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.
\- 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.
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.
Study Oversight
Has Oversight DMC:
False
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?: