Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 10:23 PM
Study NCT ID:
NCT06364657
Status:
TERMINATED
Last Update Posted:
2025-01-15
First Post:
2024-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Role of Neurotrophic Keratitis Versus Severity of Tear Film and Ocular Surface Parameters in Determining the Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IIR
Brief Summary:
In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:
1. To determine whether dry eye is associated with reduced corneal sensation
2. To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation.
1. To determine whether dry eye is associated with reduced corneal sensation
2. To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: