Healthy adults
Conditions
Interventions
Duration: 4 weeks Test material: Soft capsule contained 7.5 mg of crocetin One capsule per day
Duration: 4 weeks Test material: placebo soft capsule One capsule per day
Sponsors
ORTHOMEDICO Inc.
Seisin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Healthy adults with a subjective symptom of eye fatigue. b) Males and females aged 20 to 40 years old. c) Persons who routinely use a TV game and PC or act the VDT more than 4 hour per day. d) Persons who routinely don`t use a glass or screen of blocking blue-light. e) Persons whose corrected visual acuity in both eyes is more than 1.0 and who don`t use contact lenses.
Exclusion criteria
Exclusion criteria: a) Persons who have previous medical history of malignant tumor, or heart failure and/or myocardial infarction. b) Patients being treated for at least one of following diseases: atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or other chronic disease. c) Persons who have ophthalmopathy or entropion or trichiasis. d) Persons who have ametropia and don`t be treated orthoptics properly. e) Persons who are strong astigmatism. f) Persons who are achromatopsia. g) Persons who were treated with LASIK. h) Persons who have cause of eyestrain except for neurological deficit,et al. or regulatory function. i) Persons who take medicines or herbal medicines. j) Persons who take dietary supplements. k) Persons who are allergic to medicines or foods related to the test material of this trial. l) Pregnant women, lactating women, or women who plan to get pregnant during the trial period. m) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial. n) Smokers o) Persons judged not suitable to participate in this trial by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accommodative function (Percentage of pupil constriction) (0, 4 week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires (VAS) Schirmer's test Tear film break-up time (0, 4 week) | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed