Healthy Japanese
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Ario Nishiarai Eye Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Individuals who feel eye strain when performing VDT operation 6. Individuals whose monocular visual acuity is 1.0 or better with the unaided eye or corrected eye (whichever is worse) 7. 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) 8. Individuals who the difference of visual acuity from VDT load (after load-before load) are large negatively
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently 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 taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test product related products 7. Individuals who are diagnosed with presbyopia, or have presbyopia in self-knowledge 8. Individuals who have eye disease, entropion or trichiasis 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 who have excessive astigmatism 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. 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 another study during this study 15. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of dominant eye visual acuity at 12 weeks after intervention (12w) [Before and after visual display terminals (VDT) workload: The change from before to after VDT workload] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change of dominant eye visual acuity from screening (before consumption; Scr) to 12w [Before and after VDT workload] 2. The measured value of dominant eye visual acuity at 12w, and the change from Scr [Before VDT workload, After VDT workload] 3. The measured values of binocular visual acuity and non-dominant eye visual acuity at 12w, and their changes from Scr [Before VDT workload, After VDT workload, Before and after VDT workload] 4. The measured values of binocular near visual acuity, dominant eye near visual acuity, non-dominant eye near visual acuity, binocular intraocular pressure, dominant eye intraocular pressure, non-dominant eye intraocular pressure, and an original questionnaire at 12w, and their change from Scr [Before VDT workload, After VDT workload, Before and after VDT workload] | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed