None listed
Conditions
Interventions
[1] Oral ingestion of a test food (1 tablet in a day
2 weeks). [2] Observation. [3] Washout (2 weeks) [4] Oral ingestion of a placebo food (1 tablet in a day
2 weeks). [5] Observation.
[1] Oral ingestion of a placebo food (1 tablet in a day
2 weeks). [2] Observation. [3] Washout (2 weeks) [4] Oral ingestion of a test food (1 tablet in a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 20-64 years. [2] Individuals who are healthy and have no chronic physical disease. [3] Individuals who are aware of eye fatigue due to daily VDT work or / and eye strain from driving a car. [4] Individuals who engage in VDT work in their everyday life for 20 hours or more per week and 5 days per week (including time spent playing video games and operating computers and cell phones). [5] Individuals who have binocular vision of 1.0 or better with naked eye or corrected vision, and who do not wear contact lenses, or are able to change to glasses during the examination period. [6] Individuals whose written informed consent has been obtained. [7] Individuals who can come to the designated venue for this study and be inspected. [8] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [4] Individuals who are a patient or have a history of or endocrine disease. [5] Individuals who used a drug to treat a disease in the past 1 month. [6] Individuals who use artificial tears more than 6 times a day in everyday life. [7] Individuals who have been diagnosed with presbyopia or are aware of presbyopia. [8] Individuals with eye diseases, entropion, or trichiasis. [9] Individuals with a confirmed diagnosis of dry eye. [10] Individuals who are using eye drops for the treatment of ocular diseases. [11] Individuals who have refractive errors and have not been properly corrected. [12] Individuals who have undergone LASIK vision restoration surgery. [13] Individuals with high intensity astigmatism. [14] Individuals whose eye fatigue is thought to be caused by a neurological disorder or other regulatory dysfunction. [15] Individuals whose BMI is over 30kg/m2 [16] Individuals with drug and food allergies. [17] Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which claim to improve eye-related functions or contain active ingredients that are expected to have an effect on the eyes in the past 3 months or will ingest those foods during the test period. [18] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [19] Individuals who may change their lifestyle during the examination period. [20] Individuals who engage in a night work. [21] Individuals who are or are possibly pregnant, or are lactating. [22] Individuals who participated in other clinical studies in the past 3 months. [23] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer's test (1) (1): Screening , Observation Period I , Observation Period II . | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Visual Analogue Scale (1) [2] Tear film break-up time (2) *Safety [1] Blood pressure, pulsation (2) [2] Weight, body fat percentage, BMI (2) [3] Doctor's questions (2) [4] Subject's diary (3) *Other index [1] Baseline characteristics (4) [2] Height measurement (4) [3] Hematologic test (4) [4] Blood biochemical test (4) [5] Urine analysis (4) [6] General ophthalmologic examination (visual acuity, intraocular pressure measurement, fundus examination, slit-lamp microscopy, dominant eye judgement, refraction test) (4) (1): Observation Period I, Observation Period II. (2): Screening, Observation Period I, Observation Period II. (3): Everyday from the starting day of Test Period I to the last day of the study. (4): Screening. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed