UMIN-CTR Clinical Trial

Basic information
Public title	EEG and systemic effects of short wavelength light
Acronym	EEG and systemic effects of light
Scientific Title	EEG and systemic effects of short wavelength light
Scientific Title:Acronym	EEG and systemic effects of light
Region	Japan

Condition
Condition	dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate dry eye symptoms with EEG and expore associations with dry eye symptoms and other psychiatric parameters. Eye opening and closing may affect irraiation of short wavelength light and dryness.
Basic objectives2	Others
Basic objectives -Others	To evaluate the effects of dryness and short wavelength light on life and works.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ampritude and wavelength of EEG at symptomatic dry eye
Key secondary outcomes	questionnaires for psychiatric condition ocular symptoms

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Behavior,custom
Interventions/Control_1	free blinking for one minutes, then continuous eye opening for one minutes. When feeling disconfort, blink 2-3 times and repeat eye opening.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who can discontinue contact lens and eyedrop at the day of examination
Key exclusion criteria	Past corneoconjunctival surgery, lid surgery, or lacrimal surgery.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yasue Middle name Last name Mitsukura
Organization	Keio University
Division name	Technology and Engineering
Zip code	223-8522
Address	Yokohama, Japan
TEL	090-2211-8355
Email	mitsukura@keio.jp

Public contact
Name of contact person	1st name masahiko Middle name Last name ayaki
Organization	Keio University
Division name	Ophthalmology
Zip code	1608582
Address	35 shinanomachi, shinjuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	ayaki@keio.jp

Sponsor
Institute	keio university
Institute
Department

Funding Source
Organization	keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Dept of Technology, Keio univ
Address	3-14-1 hiyoshi, yokohama2238522, Japan
Tel	045-566-1455
Email	ecc-jimu@adst.keio.ac.jp

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	2019 Year 09 Month 01 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	30
Results	Under investigation
Results date posted	2019 Year 05 Month 15 Day
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	Suspended
Date of protocol fixation	2019 Year 01 Month 01 Day
Date of IRB	2018 Year 12 Month 10 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 28 Day
Last modified on	2020 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041874