UMIN-CTR Clinical Trial

Basic information
Public title	A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Acronym	A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Scientific Title	A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Scientific Title:Acronym	A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess the improvement effects on eye moisturization by oral intake of enzymatic decomposed rooster comb (INJUV(TM)) in human.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	DEQS,Visual Analogue Scale,BUT(Tear film break-up time),Schirmer's test
Key secondary outcomes	Visual acuity examination, Intraocular pressure examination,Refraction inspection,Anti-aging QOL common questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test product (4 weeks)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males and females aged 20-59 years [2]Healthy individuals without chronic diseases, including eye and skin disorders [3]Individuals who have dry eye like symptoms in their daily lives (tired eyes, rough eyes, eye dry feeling, discomfort in eyes, tingling in eyes, red eyes, difficulty in opening eyes in the morning, crumpled eyes, etc.) [4]Individuals who works with VDT (Visual Display Terminals) for 5 days or more a week (in total 20 hours or more a week including video games, PC and mobile phone operation time) [5]Individuals with corrected visual acuity of 1.0 or higher who are not wearing contact lenses or who can change to eyeglasses during the study period [6]Individuals voluntarily to join the study with written informed consent [7]Individuals who can visit study site and receive examinations on designated days [8]Individuals judged appropriate to join this study by principal investigators
Key exclusion criteria	[1]Individuals receiving medical drugs for treatment of chronic diseases [2]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication such as headache, menstrual pain, common cold, etc. [3]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [5]Individuals with history of gastrointestinal disorders except for appendicitis [6]Individuals who use artificial tears (eye drops) 6 times or more a day [7]Individuals diagnosed with presbyopia or aware of presbyopia [8]Individuals with eye disease, entropion of the eyelids, trichiasis [9]Individuals with a definitive diagnosis of dry eye [10]Individuals using eye drops to treat eye diseases [11]Individuals with refractive error and not properly corrected [12]Individuals undergoing LASIK surgery [13]Individuals with severe astigmatism [14]Individuals who are thought to have eye strain due to dysregulation such as neurosis [15]Individuals with >=30.0kg/m2 BMI [16]Individuals with drug or food allergies [17]Individuals who have a habit of continuing to take functional foods, health foods, and supplements for the purpose of improving eye function, or who plan to take them during the study period, now and within the past 3 months [18]Individuals who are currently or within the last 3 months taking health foods containing enzymatic decomposed rooster combs, hyaluronic acid, collagen, proteoglycans, elastin, or their precursors during the study period or individuals planning to take new those products [19]Individuals with alcohol intake exceeding 60g/day [20]Individuals who may significantly change their lifestyle during the study period [21]Individuals who work at night etc.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Zip code	6100394
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Toshiyasu Middle name Last name Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Zip code	1100015
Address	6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL	03-6801-8400
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	LAIMU Corporation
Institute
Department

Funding Source
Organization	LAIMU Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Society of Glycative Stress Research
Address	5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel	03-6709-8842
Email	rinri-glycativestress@antiaging-bank.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	うえのあさがおクリニック

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 08 Month 31 Day
Date of IRB	2021 Year 09 Month 10 Day
Anticipated trial start date	2021 Year 09 Month 21 Day
Last follow-up date	2021 Year 12 Month 04 Day
Date of closure to data entry	2021 Year 12 Month 05 Day
Date trial data considered complete	2021 Year 12 Month 17 Day
Date analysis concluded	2021 Year 12 Month 20 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 14 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051884