Healthy subjects
Conditions
Interventions
4-weeks Intake I period (test food) - washout period - Intake II period (placebo).
4-weeks Intake I period (placebo) - washout period - Intake II period (test food).
Sponsors
HUMA R&D CORP
Medical Corporation Hirookai Kunitachi Sakura Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese men and women between the ages of 20 and 40 at the time of obtaining consent. 2)Subject who has visual acuity of 0.7 or more in both eyes (regardless of naked eye, wearing visual acuity corrector) 3)Subject who uses video games or personal computers on a daily basis, or who perform VDT for work more than 4 hours a day. 4)Subject who has received a sufficient explanation of the purpose and contents of the research, has the consent ability, has a good. understanding, voluntarily volunteer to participate in the test, and has agreed in writing to participate in the test.
Exclusion criteria
Exclusion criteria: 1)Subject with strong myopia.(myopia of -6.0D or more) 2)Subject with pathologic myopia. 3)Subject with astigmatism of +-1.50D or more. 4)Subject with eye diseases other than refractive error. 5)Subject who can't stop using eye drops(excluding artificial tears)and eye ointments including over-the-counter drugs during the test period. 6)Subject who can't stop taking health foods(including supplements)that state effects on visual function within 1 month from the start of the test food intake, or who plans to consume them during the test period. 7)Subject who has taken health foods(including supplements)containing the components involved in the test foods within 1 month from the start of the test food intake, or who plans to consume them during the test period. 8)Subject who has undergone eye surgery, including refractive surgery. 9)Subject who has worn hard contact lenses(including orthokeratology lenses)within 1 year from the start of the test food intake, or who plans to wear them during the test. 10)Subject who has changed the power of contact lenses or eyeglasses within 1 month from the start of the test food intake, or who plans to change during the test. 11)Subject who has worn multifocal or bifocal contact lenses and progressive-refractive eyeglasses within 1 month of taking the test food intake, or who will wear it during the test. 12)Subject who has an existing disease or a history of allergy for an ingredients intaking for test food. 13)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14)Subject who has participated in other clinical trials or clinical trials within 1 month of ingestion of the test food, or who will participate in this test period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective refraction | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary evaluation item) Axis length,Subjective symptoms(VAS values),Choroid thickness,Impression questionnaire (Safety evaluation items) Vital signs, biochemistry tests, hematological tests, urinalysis, slit lamp, intraocular pressure tests, OCT tests (fundus), adverse events, side effects | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed