Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016010
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2023-08-23
Brief Title:
Efficacy and Safety of USL for Dry Eye Disease
Sponsor:
Chan-Sik Kim
Organization:
Korea Institute of Oriental Medicine
Study Overview
Official Title:
Efficacy and Safety of USL for Dry Eye Disease DED a Randomized Double-blind Placebo-controlled Parallel Phase 2 Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The objective is to compare the USL and placebo in terms of efficacy and safety and to determine the appropriate dosage
Detailed Description:
This study is a phase 2 dose-finding double-blind randomized placebo-controlled trial of two different doses of USL compared with placebo A total of 120 patients aged over 19 years with Corneal staining scoreOxford grading 2 or TBUT 10 sec and OSDI 10 points will be recruited at Daejeon University Daejeon Korean Medicine Hospital Patients will take medications two times daily for 12 weeks with 5 visiting daysscreening week 0 week 6 week 12 week 14
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?:
None