UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021158
Receipt number R000024394
Scientific Title Effect of blue light on eye and systemic health
Date of disclosure of the study information 2016/02/24
Last modified on 2023/08/30 09:04:47

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Basic information

Public title

Effect of blue light on eye and systemic health

Acronym

Effect of blue light on eye and systemic health

Scientific Title

Effect of blue light on eye and systemic health

Scientific Title:Acronym

Effect of blue light on eye and systemic health

Region

Japan


Condition

Condition

sleep disorder, metablic disorder, cornea and retinal damage, dry eye, eye fatigue

Classification by specialty

Endocrinology and Metabolism Psychosomatic Internal Medicine Ophthalmology
Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of blue light contained in daily lighting on ocular and systemic health

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary outcomes:Sleep quality
Assessment at;[1] before each intervention, [2]one month, and [3]three months for intervention 1.

Key secondary outcomes

Key secondary outcomes:Metabolic parameters, vision, cornea and retinal damage, ocular symptoms.
Assessment at;[1] before each intervention, [2]one month, and [3]three months for intervention 1.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Washout period is two weeks when subjects live regular life as precisely as possible, specifically, no oversea travel or overnight work. blue light shield for 3 hours before bedtime for 3 months

Interventions/Control_2

Washout period is two weeks when subjects live regular life as precisely as possible, specifically, no oversea travel or overnight work.Then the subjects ordinary life without blue light shield for one month

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Heathy subject proven by general health check.

Key exclusion criteria

Severe cataract or glaucoma.Vision worse than 16/20.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name masahiko
Middle name
Last name masahiko ayaki

Organization

Keio University School of Medicine

Division name

Ophthalmology

Zip code

1608582

Address

35 Shinanomachi, Shijyuku, Tokyo, Japan

TEL

090-2211-8355

Email

mayaki@olive.ocn.ne.jp


Public contact

Name of contact person

1st name masahiko
Middle name
Last name masahiko ayaki

Organization

Keio Univ Sch of Med

Division name

Ophthalmology

Zip code

1608582

Address

35 Shinanomachi, Shinjyuku

TEL

090-2211-8355

Homepage URL


Email

mayaki@olive.ocn.ne.jp


Sponsor or person

Institute

Dept of Ophthalmol, Keio Univ Sch of Med

Institute

Department

Personal name



Funding Source

Organization

personal fund

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

NOne

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tsukuba central Hospital

Address

Kashiwada 1589-3, Ushiku, Ibaragi

Tel

029-872-1771

Email

mayaki@olive.ocn.ne.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

2016 Year 02 Month 24 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

Main results already published

Date of protocol fixation

2015 Year 12 Month 09 Day

Date of IRB

2015 Year 12 Month 09 Day

Anticipated trial start date

2015 Year 12 Month 10 Day

Last follow-up date

2031 Year 12 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 23 Day

Last modified on

2023 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024394


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name