Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Pintokurukashisu Administration: Take three tablets once per day at any time between lunch and dinner with water without chewing. * If you forget to take the test
Sponsors
ORTHOMEDICO Inc.
Ario Nishiarai Eye Clinic Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese 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, hemorrhagic disorder, intestinal disorder, 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 regularly take or may take antihypertensives, antiplatelet drug or anticoagulants 14. Subjects who may use anesthetics during the test period, such as surgery 15. Subjects who are allergic to medicines and/or the test food related products 16. Subjects who are pregnant, breast-feeding, and planning to become pregnant 17. 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 18 Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of change of percentage of pupillary response (average of both eyes) before and after VDT load between at examination before the start of test-food consumption (screening) and after four-week test-food consumption (4w). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of percentage of pupillary response (average of both eyes) before VDT load and after VDT load at examination after 4w 2-1. The measured value of percentage of pupillary response (average of both eyes, dominant eye, non-dominant eye) before VDT load and after VDT load at examination after 4w 2-2. The amount of change of percentage of pupillary response (average of both eyes) before VDT load and after VDT load between at screening and after 4w 3-1. The measured value of flicker value (average of both eyes, dominant eye, non-dominant eye) before VDT load, after VDT load, and before and after VTD load at examination after 4w 3-2. The amount of change of flicker value (average of both eyes, dominant eye, non-dominant eye) before VDT load, after VDT load, and before and after VTD load between at screening and after 4w 4-1. The measured value of "blood flow velocity", "visibility of vessels", "density of vessels", "diameter of vessels", "distance between vessels", "length of vessels" and "shape of vessels" before VDT load, after VDT load, and before and after VTD load at examination after 4w 4-2. The amount of change of "blood flow velocity", "visibility of vessels", "density of vessels", "diameter of vessels", "distance between vessels", "length of vessels" and "shape of vessels" before VDT load, after VDT load, and before and after VTD load between at screening and after 4w 5. The ratio of number of subjects of each shape of blood vessel after 4w 6-1. The measured value of subjective symptoms before VDT load, after VDT load, and before and after VTD load at examination after 4w 6-2. The amount of change of subjective symptoms before VDT load, after VDT load, and before and after VTD load between at screening and after 4w 7. The ratio of number of subjects of improving subjective symptoms be | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed