Healthy Japanese subjects
Conditions
Interventions
Duration: 6 weeks Test food: Active capsule Administration: Take two capsules per day after breakfast with water. * If you forget to take the test food, take it as soon as you remember within the
Sponsors
ORTHOMEDICO Inc.
Ario Nishiarai Eye Clinic Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are experiencing eye fatigue when they work on Visual Display Terminals (VDT) operation 3. Subjects who have corrected vision of both eyes with 1.0 or more and who do not use contact lenses, or who can switch to using eye glasses during the test period 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects whose percentage of pupil constriction (average of both eyes) dropped at a relatively larger rate before and after VDT load at screening and examination before ingestion
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who were diagnosed as presbyopia or are aware of presbyopia 5. Subjects who have eye diseases, entropion or trichiasis 6. Subjects who use eye drops for treatment of eye diseases 7. Subjects who have ametropia and do not be treated orthoptics properly 8. Subjects who were treated with LASIK 9. Subjects who are strong astigmatism 10. Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function) 11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 12. Currently taking medicines (include herbal medicines) and supplements 13. Subjects who are allergic to medicines and/or the test food related products 14. Subjects who are pregnant, breast-feeding, and planning to become pregnant 15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 16. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of pupillary response (average of both eyes) *Compare the amount of change between before and after VDT load on between two groups at screening (before consumption) and 6 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of pupillary response 1-1. average of both eyes 1-2. dominant eye 1-3. non-dominant eye 2. BUT (tear film break-up time) 2-1. average of both eyes 2-2. dominant eye 2-3. non-dominant eye 3. visual acuity 3-1. average of both eyes 3-2. dominant eye 3-3. non-dominant eye 4. Value of Schirmer's test 4-1. average of both eyes 4-2. dominant eye 4-3. non-dominant eye 5. Macular Pigment Optical Density (MPOD) level 5-1. average of both eyes 5-2. dominant eye 5-3. non-dominant eye 6. Muscle hardness 7. Questionnaire (the Likert scale) *1-1Assess at screening (before consumption) and 6 weeks after consumption, and compare between two groups for the measured values at before and after VDT load. *1-2, 1-3, 3, 6, 7 Assess at screening (before consumption) and 6 weeks after consumption, and compare between two groups for the measured values at before and after VDT load, and the amount of change between before and after VDT load. *2, 4, 5 Compare the measured values on between two groups at screening (before consumption) and 6 weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed