Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055841) titled 'Evaluation test for improvement of eye fatigue by single intake of test food' on Oct. 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effect of a single intake of the test food on ocular fatigue.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - [1] Oral ingestion of a test food (1 tablet).
[2] Observation.
[3] Oral ingestion of a placebo food (1 tablet).
[4] Observation.
Interventions/Control_2 - [1] Oral ingestion of a placebo food (1 tablet).
[2] Observation.
[3] Oral ingestion of a test food (1 tablet).
[4] Observation.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Japanese males and females aged 20-64 years.
2) Individuals who are healthy and are not received treatment of disease.
3) Individuals who feel eye fatigue and thirst
4) Individuals who have binocular vision of 0.7 or better with naked eye or corrected vision, and who do not wear contact lenses.
5) Individuals whose written informed consent has been obtained.
6) Individuals who can come to the designated venue for this study and be inspected.
7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria - 1)Individuals using medical products.
2)Individuals with a confirmed diagnosis of dry eye or suspected dry eye.
3)Individuals who are using eye drops for the treatment of ocular diseases.
4)Individuals who have been diagnosed with presbyopia or are aware of presbyopia.
5)Individuals with eye diseases, entropion, or trichiasis.
6)Individuals who have a history of LASIK vision restoration surgery or intraocular lens surgery.
7)Individuals who use artificial tears more than 6 times a day in everyday life.
8)Individuals who regularly use contact lenses to correct their vision.
9)Individuals with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, eye disease or serious illness.
10)Individuals with a serious or current medical history of liver, kidney, heart, lung, blood, etc.
11)Individuals who are a patient or have a history of or endocrine disease.
12)Individuals who used a drug to treat a disease in the past 1 month.
13)Individuals with drug and food allergies.
14)Individuals who are a smoker.
15)Individuals who are currently, or within the past 3 months have been, in the habit of continuously consuming functional foods, health foods, or supplements containing lactobacilli or claiming visual function, and those who plan to consume such foods during the study period.
16)Individuals who excessively take alcohol (60 g/day in pure alcohol equivalent).
17)Individuals who may change their lifestyle during the examination period.
18)Individuals who have difficulty in inputting text in English using a personal computer and persons who can easily input text using a personal computer.
19)Individuals who engage in a night work.
20)Individuals who are or are possibly pregnant, or are lactating.
21)Individuals who participated in other clinical studies in the past 3 months.
22)Individuals who are or whose family is engaged in healthy or functional foods.
23)Individuals judged inappropriate for the study by the principal.
Target Size - 28
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 09 Month 20 Day
Date of IRB - 2024 Year 09 Month 25 Day
Anticipated trial start date - 2024 Year 11 Month 09 Day
Last follow-up date - 2024 Year 11 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063569
Disclaimer: Curated by HT Syndication.
