Verification study of the effect of a single intake of the test food on dry eyes and eyestrain

UMIN ID: UMIN000041665

Registered date:12/09/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2020/09/13
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingest 100ml high concentration test beverage at room temperature
Ingest 100ml low concentration test beverage at room temperature
Ingest 100ml placebo beverage at room temperature

Outcome(s)

• Primary Outcome: Tear strage Near point distance measurement
• Secondary Outcome: Tear layer destruction time Questionnaire about eye symptoms amount of saliva

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude criteria: 1. Those who are currently receiving some types of drug (except for the drugs that are taken as needed). Cholinergic agonists and anticholinergic drugs are not allowed even for abortive use (e.g., for use in stomach medicine and treatment of hyperhidrosis). 2. Those who have some kind of eye treatment (including dry eye). 3. Those who have had eye surgery within one year of the screening test and those who are planning to have eye surgery (including LASIK surgery) during the study period 4. People with serious or progressive diseases or symptoms (such as those for which drugs are used regularly on a daily basis) 5. Those who take health foods (foods or supplements that affect the body's composition, or are intended to maintain or restore health). 6. Those who have a past and current medical history of drug or food allergy. 7. Those who are participating in or currently participating in another clinical trial within one month prior to obtaining consent. 8. Pregnant, wishing to become pregnant between the screening date and the end of the food study, and breastfeeding 9. Those who regularly take foods containing lactobacillus and who have ingested dairy products (yogurt, kefir, sour cream, cheese, fermented butter, lactic acid bacteria drinks) containing lactobacillus even once within the past 7 days. 10. Those who plan to take dairy products containing lactobacillus (yogurt, kefir, sour cream, cheese, fermented butter, lactic acid bacteria drink) from the screening date to the end of the test period. 11. People with hay fever 12. Those who the investigator has determined to be inappropriate for this study.

Related Information

• Primary Sponsor: IMEQRD Co., Ltd.
• Source(s) of Monetary Support: Asahi Quality & Innovations, Ltd.