Efficacy and Safety of USL for Dry Eye Disease (DED): a Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- USL
- Conditions
- Dry Eye Disease
- Sponsor
- Chan-Sik Kim
- Enrollment
- 120
- Primary Endpoint
- TBUT(Tear break-up time)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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 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).
Investigators
Chan-Sik Kim
Principal Investigator
Korea Institute of Oriental Medicine
Eligibility Criteria
Inclusion Criteria
- •Aged over 19
- •Screening both eyes, the corrected visual acuity is 0.2 or more
- •Subjects with Fluorescein Corneal Staining score (Oxford grading) ≥ 2 or TBUT test ≤10 at screening
- •Subjects with OSDI ≥ 13
- •Subjects who voluntarily agreed to participate in this clinical study in written form
Exclusion Criteria
- •Current or history of ocular disorders possibly affecting the study results (ocular surgery, trauma, diseases) as followings within 2 months:
- •Abnormal eyelid function: disorders of the eyelids or eyelashes
- •Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
- •Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation
- •Those with acute eye inflammation/infection within 1 month
- •Those who have undergone eye surgery (including LASIK/LASIK) within 3 months
- •Those who had taken lacrimal punctal occlusion, cauterization of the punctum, or intense pulsed light procedure within 3 months
- •Those who wear contact lenses within 72 hours of screening or plan to wear contact lens during the study period
- •Intraocular pressure (IOP)\> 25 mmHg in more than one side
- •Autoimmune disease (e.g., Sjogren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease)
Arms & Interventions
Standard-dose USL group
2 tablets(1 USL, 1 placebo) b.i.d for 12 weeks
Intervention: USL
Standard-dose USL group
2 tablets(1 USL, 1 placebo) b.i.d for 12 weeks
Intervention: USL Placebo
High-dose USL group
2 tablets(2 USL) b.i.d for 12 weeks
Intervention: USL
Placebo group
2 tablets(2 placebo) b.i.d for 12 weeks
Intervention: USL Placebo
Outcomes
Primary Outcomes
TBUT(Tear break-up time)
Time Frame: Screening, 6 week, 12 week, 14 week
The tear break-up time test measures the time in seconds. The time is from the last blinking to the point of tear layer defect or streak-like defect after blinking the eye with 1% of fluorescein. 10 seconds or more as normal, between 5 and 10 seconds as mild dry eye syndrome, and 5 seconds or less as severe dry eye syndrome.
Secondary Outcomes
- OSDI(Ocular Surface Disease Index)(Screening, 6 week, 12 week, 14 week)
- VAS(Visual analog scale)(0 week, 6 week, 12 week, 14 week)
- Schirmer's test(0 week, 6 week, 12 week, 14 week)
- Meibomian gland test(0 week, 6 week, 12 week, 14 week)
- Fluorescein corneal staining score - Oxford grading(Screening, 6 week, 12 week, 14 week)
- SPEED-II (Standard Patient Evaluation for Eye Dryness-II)(0 week, 6 week, 12 week, 14 week)
- Biomarkers(0 week, 12 week)