healthy subject
Conditions
Interventions
Test sample 1 (60mg/day): capsules containing MaquiBright 60mg and dextrin
Test sample 2 (120mg/day): capsules containing MaquiBright 120mg and dextrin
Placebo: capsules containing dextrin only
Sponsors
Tsubota-lab
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy subjects, male and female aged from 30 to 60 years old (the ages are judged on the day signed the declaration of Consent) 2) Oneself feeling to have the three symptoms (dry eye, eye fatigue, and dull feeling) 3) Naked eye or wearing glasses
Exclusion criteria
Exclusion criteria: 1.Subjects diagnosed with definite dry eye by Diagnosis Criteria of Dry Eye 2.Subjects wearing contact lenses. 3.Subjects consuming dietary supplement(s) or over the counter drug(s) included eye drops within participation one month. 4.Subjects are likely to change the number of times using artificial tears a day. 5.Subjects using artificial tears more than seven times a day. 6.Subjects who are using dry eye treatment drugs (However,it is selectable that the subjects have passed two weeks after discontinuation using a dry eye treatment drug, and do not use the drug during this study.) 7.Subjects who are currently suffering any ophthalmic disease (including conjunctival laxity),or anamnesis with serious eye disease 8.Subjects who are using eye drops for other ophthalmic diseases 9.Subjects diagnosed with Sjogren's syndrome 10.Subjects at risk of developing hay fever during October to january 11.Subjects with chronic disease of asthma 12.Subjects in medication, or who have anamnesis with serious eye disease that require medication 13.Subjects who underwent eye surgery during the past 3 months 14.Subjects who are allergic to the test sample 15.Subjects who had participated in other clinical trial within one month prior to the participation agreement of this study,or who are planning to participate in other clinical trials after the participation agreement of this study 16.Subjects who are planning pregnancy or breast-feeding during the study period 17.Others,subjects who are determined to be inappropriate as a subject by the doctor or researcher responsible for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tear film break-up time (BUT examination), strip meniscometry, Schirmer 1 test, subjective symptoms questionnaire (DEQS, VAS);investigation at start, 4 weeks treatment and after 8 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| corneal and conjunctival epithelial disorder score, meibomian glands (MG) evaluation, continuous near-point measurement and flicker vision, visual acuity | — |
Countries
Japan
Contacts
Public ContactShintaro Yamada
Tsubota-lab Director
Outcome results
None listed