Healthy adults
Conditions
Interventions
Intake of the test food for 4 weeks
Intake of the placebo food for 4 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males from 20 to 64 years old. (2) Subjects who are concerned about dry eyes. (3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of mental illness, diabetes,liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (2) Subjects with a history of ocular disease or eye surgery. (3) Subjects currently receiving ophthalmologic treatment. (4) Subjects using anti-inflammatory eye drops (e.g., steroids, cyclosporine, lifitegrast) or anti-allergic eye drops (e.g., olopatadine, epinastine, ketotifen). (5) Subjects taking prescription or over-the-counter medications including anticholinergics, antihistamines, antidepressants, beta-blockers, isotretinoin, etc. (6) Subjects who wear contact lenses. (7) Subjects with a history of gastrointestinal surgery. (8) Subjects with abnormal liver or kidney function test results. (9) Subjects currently undergoing treatment for any disease. (10) Subjects who are allergic to the foods in this study. (11) Females who are pregnant, breastfeeding, or planning to become pregnant during the study period (including those who may be pregnant). (12) Subjects with a tear film break-up time (BUT) of 5 seconds or less. (13) Subjects who engage in intense sports activities or are currently on a diet. (14) Subjects with extremely irregular dietary or lifestyle habits. (15) Subjects who cannot refrain from consuming health foods (including Foods for specified health uses, foods with functional claims, and supplements) or designated quasi-drugs during the study period. (16) Subjects who are continuously undergoing treatment with medications (including OTC and prescription drugs). (17) Subjects whose average daily alcohol consumption exceeds 40 g of pure alcohol. (18) Smokers. (19) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study. (20) Other subjects judged by the investigator or the investigator to be inappropriate for the examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Break-up time (BUT) of the tear film | — |
Secondary
| Measure | Time frame |
|---|---|
| Japanese version of the oscular surface disease index(J-OSDI) Simple questionnaire regarding eye condition | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed