Trials / Unknown
UnknownNCT06016010
Efficacy and Safety of USL for Dry Eye Disease
Efficacy and Safety of USL for Dry Eye Disease (DED): a Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Clinical Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Chan-Sik Kim · Other Government
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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 score(Oxford 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 days(screening, week 0, week 6, week 12, week 14).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | USL | 500mg of Achyranthis Radix Extract |
| DRUG | USL Placebo | USL Placebo |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2023-08-29
- Last updated
- 2023-09-11
Source: ClinicalTrials.gov record NCT06016010. Inclusion in this directory is not an endorsement.