Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-01 @ 8:11 PM
Study NCT ID:
NCT04775303
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
An Investigator Initiated Multi-center Phase 4 Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients With Inadequate Effects From Previous Treatment (IKE-03, Switching Study)
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
None
Brief Summary:
A clinical trial to evaluate the efficacy and safety of Cyclosporine 0.1% (Ikervis®) for moderate to severe dry eye patients who changed to Cyclosporine 0.1% eye drop(Ikervis®) due to lack of treatment effects of the previous Cyclosporine 0.05% eye drop.
Detailed Description:
Eligible patients who agree to participate in the clinical trial in writing will be administered Cyclosporine 0.1% eye drop(Ikervis®) one drop once daily for 12 weeks. Efficacy and safety will be evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.
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?:
None
Is an FDA AA801 Violation?: