Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Test food
Duration: 12 weeks Test product: Placebo
Sponsors
Nippon Shinyaku Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 20 or more and less than 65 4. Healthy individuals 5. Individuals whose monocular visual acuity is 1.0 or better with the unaided eye or corrected eye (whichever is worse) 6. Individuals who do not wear contact lenses or who wear contact lenses but can change to glasses during this study (between the date of consent and the final examination) 7. Individuals who are aware of dry eye-like symptoms in daily life (e.g., eye strain, a gritty sensation, a feeling of dryness, or ocular discomfort) 8. Individuals with a Break Up Time (BUT) > 5 seconds in both eyes at Scr 9. Individuals with low lacrimal secretion volume at Scr
Exclusion criteria
Exclusion criteria: Individuals who 1. receive treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. receive treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 4. take Foods for Specified Health Uses or Foods with Functional Claims, particularly those who take or plan to take such foods or supplements that claim to improve eye-related functions 5. receive treatment for eye conditions 6. have diseases related to the lacrimal glands or Meibomian glands, such as dry eye 7. have undergone eye surgery within 1 year before Scr, or plan to undergo eye surgery during this study 8. have used eye drops, including over-the-counter (OTC), within 2 weeks before Scr 9. are unable to discontinue the use of eye drops, including OTC, during this study 10. use or plan to use cholinergic agents, anticholinergic agents, or herbal medicines used to alleviate dry eye symptoms 11. are diagnosed with presbyopia 12. have undergone laser in situ keratomileusis 13. have hay fever or allergic conjunctivitis 14. have a history or currently have drug or food allergies 15. plan to make significant changes in their lifestyle (e.g., diet, sleep, or exercise) 16. work night shifts or other rotating shifts 17. have a history or currently have dependence on alcohol, hypnotics, central analgesics, or psychotropic drugs 18. have a history or currently have psychiatric disorders 19. take medicines (including herbal medicines) or supplements 20. are pregnant, lactating, or planning to become pregnant during this study 21. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study 22. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of binocular lacrimal secretion volume at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of blood pentosidine at 12w 2. The change and percentage change from screening (Scr) of binocular lacrimal secretion volume at 12w 3. The measured values of lacrimal secretion volume of the dominant eye and non-dominant eye; eye dryness, eye strain, glare, itchy eyes, visual field narrowness, neck stiffness, shoulder stiffness, lower back stiffness, oral dryness assessed by self-reported symptom questionnaire (VAS); and DEQS summary score, bothersome ocular symptoms, and impact on daily life at 12w, and their changes and percentage changes from Scr 4. Individuals whose responses to each item of the DEQS improved by one or more scales at 12w compared with Scr 5. Individuals who experienced adverse events 6. Individuals whose urinalysis and peripheral blood test values were within the reference range at Scr but became outside the reference range after intervention 7. Physical measurements, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed