None listed
Conditions
Interventions
Dietary Supplement, Others(Health functional food) : Take the test food (EYESOY®) or placebo twice daily (morning and evening) for 12 weeks, one capsule each time, with sufficient water.
Sponsors
WiLab
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female adults aged =19 years and <65 years 2) Individuals who use electronic devices such as monitors and mobile phones for at least 4 hours per day and complain of eye fatigue 3) Individuals with bilateral TBUT of less than 10 seconds at Visits 1 and 2 4) Individuals who agree to participate in this human clinical trial prior to its initiation and sign a written informed consent form (Informed Consent Form, ICF)
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urinary, neurological, musculoskeletal, psychiatric, infectious diseases, or malignant tumors 2) Individuals who have undergone refractive surgery such as LASIK within 12 months prior to Visit 1 3) Individuals with a history of ocular surgery within 6 months prior to Visit 1, or a history of ocular disease (excluding dry eye syndrome) within 3 months prior to Visit 1 4) Individuals with alcohol use disorder or substance-induced disorder, or central nervous system disorders 5) Individuals who have used medications that may affect dry eye within 1 month prior to Visit 1 (e.g., dry eye treatments, diuretics, medications for autoimmune or thyroid diseases, antihistamines, beta-blockers, tricyclic antidepressants, estrogen hormone preparations, or progesterone preparations) 6) Individuals who have used artificial tears within 1 week prior to Visit 1 7) Individuals who have worn contact lenses within 2 weeks prior to Visit 1 8) Individuals who have taken eye health functional foods or vitamin-containing functional foods within 1 week prior to Visit 1 9) Individuals who have consistently (=4 times per week) consumed soy-based processed foods (e.g., soy milk, powdered meal substitutes, soy tea) within 1 week prior to Visit 1 10) Individuals with intraocular pressure (IOP) =25 mmHg 11) Individuals with irregular lifestyles such as night shift work 12) Individuals with uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg after 10 minutes of rest prior to assessment) 13) Individuals with uncontrolled diabetes mellitus (fasting blood glucose =180 mg/dL or initiation of new antidiabetic medication within 3 months) 14) Individuals with TSH =0.1 µIU/mL or =10 µIU/mL 15) Individuals with creatinine =2 times the upper limit of normal for the testing site 16) Individuals with AST (GOT) or ALT (GPT) =3 times the upper limit of normal for the testing site 17) Individuals who are pregnant, breastfeeding, or planning pregnancy during the study period 18) Individuals with hypersensitivity or allergy to any components of the investigational product 19) Individuals who have participated in another interventional clinical trial (including human clinical studies) within 3 months prior to Visit 1, or who plan to participate in another interventional clinical trial during this study 20) Individuals deemed inappropriate for participation in this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Film Break-Up Time | — |
Secondary
| Measure | Time frame |
|---|---|
| Schirmer’s test;Meibomian gland score;Non-invasive tear break-up time;Tear film lipid layer thickness, conjunctival hyperemia grade, tear secretion test;Corneal fluorescein staining;Ocular Surface Disease Index;Visual analogue scale;National Eye Institute Visual Function Questionnaire-25 | — |
Countries
Korea, Republic of
Contacts
Public ContactHyung-bin Hwang
The Catholic University of Korea, Incheon St. Mary's Hospital
Outcome results
None listed