N/A (healthy adults)
Conditions
Interventions
12 weeks)
Oral intake of the placebo food (1 pill in a day
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and Females aged 20-74 years [2]Individuals whose intraocular pressure is over 20mmHg at Week 0 [3]Individuals whose written informed consent has been obtained [4]Individuals who can have an examination in a designated day [5]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals having glaucomatous optic disc disorder. [2]Individuals with serious disease. [3]Individuals with eye disease which has influence to intraocular pressure and measurement of ocular tension (ex. inflammatory disease, corneal disease). [4]Individuals who used a drug having influence to intraocular pressure in the past 4 weeks. [5]Individuals who have to wear contact lens from bedtime of the day before to the completion of the inspection at each visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Value and rate changes of intraocular pressure (Screening vs Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes Value and rate changes of intraocular pressure (Screening vs Week 4; Screening vs Week 8) *Safety [1]Doctor's questions [2]Blood pressure, pulsation [3]Weight, body fat percentage, BMI [4]Blood test (adiponectin) [5]Blood biochemical test [6]Urine analysis *Other outcomes Subject's diary(From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed