Status:
UNKNOWN
Efficacy and Safety of USL for Dry Eye Disease
Lead Sponsor:
Chan-Sik Kim
Conditions:
Dry Eye Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
- Genetic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Comorbidities that may interrupt the treatment of cancers or clinically significant disorders of the kidney, liver, psychiatric system, cardiovascular system, respiratory system, endocrine system, and central nervous system, the safety assessment, or completion of this clinical study
- Unregulated hypertension (high blood pressure of 160 mmHg in the condenser or high blood pressure exceeding 100 mmHg in the relaxation period)
- Unregulated diabetes (fasting blood sugar (FBS) exceeding 180 mg/dL)
- Hepatitis A (active) or hepatitis B (active) or hepatitis C
- History of hypersensitivity reaction to active ingredients or excipients of the investigational product
- History of excessive alcohol use or drug addiction
- Pregnant or lactating women
- Those who did not agree to use contraception by medically permitted methods (e.g., surgical treatment of infertility, intrauterine device, condom or diaphragm, and injectable or insertable contraceptives) during the period from dosing of the investigational product to 90 days after the clinical study, among female subjects of childbearing potential and male subjects with the female partner
- Those who had experience of participating in a different clinical study within 4 weeks prior to participation in this clinical study
- Subjects who were determined to be ineligible to participate in this study
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06016010
Start Date
January 1 2024
End Date
December 31 2025
Last Update
September 11 2023
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