Efficacy and Safety of USL for Dry Eye Disease

NCT06016010 | Unknown Phase 2

• 1 other identifier: KIOM_2301_DED_USL
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective is to compare the USL and placebo in terms of efficacy and safety, and to determine the appropriate dosage.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• TBUT(Tear break-up time)

  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.

  Screening, 6 week, 12 week, 14 week

Secondary Outcomes (7)

• 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

Study Arms (3)

Standard-dose USL group

EXPERIMENTAL

2 tablets(1 USL, 1 placebo) b.i.d for 12 weeks

Drug: USL; Drug: USL Placebo

High-dose USL group

EXPERIMENTAL

2 tablets(2 USL) b.i.d for 12 weeks

Drug: USL

Placebo group

PLACEBO COMPARATOR

2 tablets(2 placebo) b.i.d for 12 weeks

Drug: USL Placebo

Interventions

USL DRUG

500mg of Achyranthis Radix Extract

High-dose USL group; Standard-dose USL group

USL Placebo DRUG

USL Placebo

Placebo group; Standard-dose USL group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Those who have used cyclosporine or diquafosol use in any form (systemic, topical) within 1 month
• Medical condition or history within 1 month to be treated with topical agents besides artificial tears (glaucoma, ocular allergy, ocular inflammation/infectious disease, etc.)
• Those who have taken or are taking steroid drugs or immunosuppressants (Azathioprine, Tacrolimus, Cyclosporin, Mycophenolate mofetil etc.) that may affect immune function within 3 months prior to screening
• Those who had taken antihypertensive drugs such as antihistamine and beta blockers, diuretics, antidepressants (especially tricyclic antidepressants, Parkinson's treatment drugs, etc.) that can worsen dry eye cannot participate in this study
• Severe abnormal liver function tests (Alanine transaminase (ALT) or Aspartate transaminase (AST) values ≥ 2 times the upper limit of normal) and abnormal renal function (Creatinine values ≥ 2 times the upper limit of normal)

Sponsors & Collaborators

• Chan-Sik Kim: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Chan-Sik Kim, PhD

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee Ran Lyu, PhD

CONTACT

82-10-9904-8049; onedoctor2ran@kiom.re.kr

Chan-Sik Kim, PhD

CONTACT

82-10-3018-0213; chskim@kiom.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share