Healthy Japanese adults
Conditions
Interventions
Duration: 12 weeks Test materials: Bilberry extract contained in capsule Dose: Take a capsule once a day (550 mg) Administration: Take a capsule after breakfast. *If you forget to take the caps
Sponsors
ORTHOMEDICO Inc.
Ario Nishiarai Eye Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 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 principal investigator 5. Among the subjects who passed 4., 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. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who were diagnosed as presbyopia or are aware of presbyopia 4. Subjects who have eye diseases, entropion or trichiasis 5. Subjects who use eye drops for treatment of eye diseases 6. Subjects who have ametropia and do not be treated orthoptics properly 7. Subjects who were treated with LASIK 8. Subjects who are strong astigmatism 9. Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function) 10. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage which effective for visual function improvement, or other functional food/beverage in daily 11. Currently taking medicines (include herbal medicines) and supplements 12. Subjects who are allergic to medicines and/or the test food related products 13. Subjects who are pregnant, breast-feeding, and planning to become pregnant 14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 15. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accommodative function * Assess these at screening and examination day before consuming, and at 4, 8, and 12 weeks after consuming. Perform the test before and after 60 minutes VDT load. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Night time visual acuity test (the recovery time of light adaptation) 2. Visual Analogue Scale (VAS) of subjective symptoms *1,2 Assess these at screening and examination day before consuming, and at 4, 8, and 12 weeks after consuming *1 Perform the test before 60 minutes VDT load. *2 Perform the test before and after 60 minutes VDT load and following a 15 minutes rest after | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed