UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	sensibility evaluation among different lighting condition
Title of the study (Brief title)	sensibility evaluation among different lighting condition
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate which lighting condition is comfortable among glare light and 2 kinds of glare-less light.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain wave
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	normal lighting
Interventions/Control_2	glare-less lighting 1
Interventions/Control_3	glare-less lighting 2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy adults
Key exclusion criteria	1.participants who are currently under treatment of eye disease 2.participants who have brain disease (such as dementia and epilepsia
Target sample size	20

Research contact person
Name of lead principal investigator	Motoko Kawashima
Organization	Keio University School of Mdeicine
Division name	Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3972
Email	motoko-k@a3.keio.jp

Public contact
Name of contact person	Motoko Kawashima
Organization	Keio University School of Medicine
Division name	Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3972
Homepage URL
Email	motoko-k@a3.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	ModuleX Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 11 Day
Anticipated trial start date	2017 Year 11 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 20 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034301