Healthy adults
Conditions
Interventions
Duration: 8 weeks Test material: lutein One capsule two times per day before breakfast and dinner
Duration: 8 weeks Test material: placebo One capsule two times per day before breakfast and dinn
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Persons who are between 30 and 49 years old b) Persons who are aware of dry eyes 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 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 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, herbal medicines j)Persons who are allergic to medicines, or products related to the test material of this trial k)Pregnant women, lactating women, or women who want to get pregnant during the trial period l)Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial m)Persons who are judged not suitable to participate in this trial by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of oxidative stress Pigment amount of macula lutea Dry eye evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires Likert scale Safety test Physical examination Urine analysis Blood chemical analysis Visual acuity test | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed