Glaucoma
Conditions
Interventions
Oral intake of test food (1 pill in a day, 4 weeks)
Sponsors
Shimane University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and Females aged 20 years over and aged under 70 years old [2] Individuals whose written informed consent has been obtained [3]Individuals whose both eye were prevent from glaucoma progression by treating with 1 to 3 medication, and individuals who do not need the ophthalmic surgery including glaucoma operation [4] Individuals who want to take the test food [5] Individuals whose intraocular pressure was higher than 15 mmHg with Goldmann applanation tonometer in at least one eye. [6] Individuals who can measure the intraocular pressure with ICare HOME tonoometer [7] Individuals whose measuring times of intraocular pressure with ICare HOME tonometer in pre-dosing period were greater than (days of pre-dosing period x2) times
Exclusion criteria
Exclusion criteria: [1] Individuals with serious systematic disease [2] individuals with ocular disease which may leads the blindness except glaucoma or mild cataract [3] Individuals with hepatic or renal failure, cardiac failure, renal failure which having influence to supplement evaluation. [4] individuals with cigarettes smoker [5] Individuals who continuously used a antioxidative supplement or have plan to use said supplements during the study period [6] Individuals who are likely to change the lifestyle (long journey, change in Eating habits etc.). [7] Individuals who is pregnant, lactating, or may possibly be pregnant. [8] Individuals who entry into another clinical trial, or has a history of the entry into other clinical trials within 3 months [9] Individuals with allergy to test food or who may possibly be allergy to test food. [10] Individuals who are inappropriate case judged by investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Value and rate changes of oxidative stress marker from pre-dosing at 4 weeks after dosing Adverse effect | — |
Countries
Japan
Contacts
Public ContactYasutaka Takagi
Santen Pharmaceutical Co., Ltd. Japan Medical Affairs Group
Outcome results
None listed