Healthy adults.
Conditions
Interventions
Duration: Four weeks Test product: Flavonoid.
Duration: Four weeks Test product: Placebo
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 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 frequently engage in VDT work and are aware of a sensation of eye dryness 8. Individuals whose Break Up Time (BUT) exceeds five seconds at Scr 9. Individuals whose lacrimal secretion after VDT workload at Scr is less than that before VDT workload
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator 3. Individuals who are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are diagnosed with presbyopia, or have presbyopia in self-knowledge 5. Individuals who have eye disease, entropion, or trichiasis 6. Individuals who are diagnosed with dry eye 7. Individuals with Sjogren's syndrome 8. Individuals with meibomian gland dysfunction 9. Individuals who apply eye drops for eye diseases 10. Individuals who have ametropia and have not been properly corrected 11. Individuals who have undergone laser in situ keratomileusis surgery 12. Individuals with severe astigmatism 13. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 14. Individuals who are taking or using medications (including herbal medicines) or supplements 15. Individuals who are allergic to medicines or foods related to the test product 16. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles 17. Individuals who currently smoke or began smoking cessation within three months before providing informed consent 18. Individuals who habitually drink >= 60 g/day of alcohol 19. Individuals who are pregnant, lactating, or planning to become pregnant during this study 20. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 21. Individuals who 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 four weeks after intervention (4w) [Before-after visual display terminals (VDT) workload: the change from before to after VDT workload] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of binocular lacrimal secretion volume at two weeks after intervention (2w) [Before-after VDT workload] 2. The changes and percentage change of binocular lacrimal secretion volume at 2w and 4w from screening (Scr) [Before-after VDT workload] 3. The measured values of dominant eye lacrimal secretion and non-dominant eye lacrimal secretion at 2w and 4w, as well as their changes and percentage changes from Scr [Before VDT workload, after VDT workload, and before-after VDT workload] 4. The measured values of eye dryness, eye strain, glare, itchy eyes, visual field narrowness, neck stiffness, shoulder stiffness, and lower back stiffness (visual analogue scale; VAS) at 2w and 4w, as well as their changes and percentage changes from Scr [Before VDT workload, after VDT workload, before-after VDT workload] 5. The measured values of QOL score, ocular symptoms, and impact on daily life in the Dry Eye related Quality of life Score (DEQS) at 2w and 4w, as well as their changes and percentage changes from Scr 6. Individuals whose responses to each item in the DEQS improved by one or more scales at 2w and 4w compared to Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed