None listed
Conditions
Interventions
Dietary Supplement : Those with dry eyes voluntarily signed on the consent form for the human application test are randomly assigned to the test group or control group according to the registration or
Sponsors
PBL Biolab
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) men and women over the age of 19 2) Those who have a teardrop destruction time (TBUT) of less than 10 seconds in Visit 1 and Visit 2 3) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has signed a written consent form
Exclusion criteria
Exclusion criteria: 1) Persons currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotropic, infectious diseases including skin, and malignant tumors 2) A person who has been vaccinated within two months on the basis of visit 1 3) A person who has been confirmed to be infected with COVID-19 within two months based on Visit 1 4) A person who has undergone vision correction surgery, such as LASIK, within 12 months on the basis of visit 1 5) A person who has a history of eye-related surgery (excluding cataract surgery) within 6 months as of visit 1 or a history of eye-related diseases (excluding dry eyes) within 3 months 6) A person who has used dry eye treatment within 3 months based on visit 1 7) A person who has used drugs that may affect dry eyes (self-immune disease treatment, thyroid disease treatment, antihistamines, beta-blockers, tricyclic antidepressants, estrogen hormones, etc.) within one month of visit 1 8) A person who wears contact lenses within two weeks of visit 1 9) A person who has administered antibiotics and intestinal medications within two weeks on the basis of visit 1 10) A person who has consumed probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks based on visit 1 11) A person who has consumed health functional foods (Omega-3s, vitamins, etc.) or health functional foods related to eye health that may affect dry eyes within one week of the visit 1 12) A person who lives irregularly, such as late-night shifts, etc 13) A person who has allergic diseases that may affect the eyeball, such as allergic rhinitis and allergic conjunctivitis 14) Alcohol use ? People with induction disorders and central nervous system disorders 15) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after stabilizing for 10 minutes) 16) Uncontrolled diabetic patients (above 180 mg/dL fasting blood glucose) 17) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 18) A person whose creatinine is more than twice the normal upper limit of the implementation agency 19) A person who is pregnant or is lactating or has a pregnancy plan during the main human body application test period 20) A person who has participated in other interventional clinical trials (including human-applied trials) within three months of the visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) after the start of this human-applied trial 21) A person who is sensitive or allergic to food ingredients for this human application test 22) A person who is deemed unsuitable for the human body application test by the tester due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TBUT(Tear film Break-Up Time) | — |
Secondary
| Measure | Time frame |
|---|---|
| NIBUT(Non-Invasive tear Break-Up Time);the thickness of the tear film lipid layer;Meiboscore;Fluorescein Staining;Schirmer’s ? test;OSDI(Ocular Surface Disease Index);K-BDI-II(Korean-Beck Depression Inventory-II);Evaluation of Examiner's Improvement;Evaluation of the improvement of the test subjects;Cytokine(IL-1ß, IL-6, IL-10), MMP-9;fecal flora;Adverse Events ;Clinical pathological examination (hematologic/hematochemical examination, urine test);Vital signs (blood pressure, pulse), body measurements (weight) | — |
Countries
Korea, Republic of
Contacts
Public ContactMartha Kim
Dongguk University Ilsan Hospital
Outcome results
None listed