UMIN-CTR Clinical Trial

Public title

Single-blind, randomized controlled trial to assess the effect of blue-light alleviation on visual fatigue in healthy volunteers

Acronym

Single-blind, randomized controlled trial to assess the effect of blue-light alleviation on visual fatigue in healthy volunteers

Scientific Title

Single-blind, randomized controlled trial to assess the effect of blue-light alleviation on visual fatigue in healthy volunteers

Scientific Title:Acronym

Single-blind, randomized controlled trial to assess the effect of blue-light alleviation on visual fatigue in healthy volunteers

Region

Japan

Condition

healthy volunteers

Classification by specialty

Adult

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effect of blue-light alleviation during visual load test on visual fatigue, physical stress, and discomfort, compared with general white light radiated from commercial desk lamp.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

change on critical flicker frequency (CFF) from before to after the visual load test

Key secondary outcomes

1. change on ocular accommodation response from before to after the visual load test
2. change on accommodative microfluctuations from before to after the visual load test
3. change on visual acuity from before to after the visual load test
4. change on manifest refraction from before to after the visual load test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Group A: blue-light alleviated desk lamp group

Interventions/Control_2

Group B: existing desk lamp group

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

22

years-old

>=

Gender

Male and Female

Key inclusion criteria

Subjects who meet all of the following criteria are included in this study.
1. subjects whose corrected visual acuity is 0.7 or higher
2. subjects who is aged from 16 to 22 at obtaining consent
3. male and female
4. Written consent form to participate in the study signed by subjects themselves after full explanation of this study and its ethical considerations. Minor subjects need additional written consent form signed by legal representative
5. subjects who can have the ophthalmological examinations at the day of the visual load tests according to the indication by the attending physicians

Key exclusion criteria

Subjects who fall into any of the following criteria are excluded from participating in the study.
1. subjects who uses glasses
2. subjects who have any anamneses or complications which could affect the results of the study, such as dry eye, ophthalmological surgery, eye inflammation including allergic reaction, ocular infection, glaucoma, keratoconus, and diabetes mellitus
3. subjects who use any eye drops, oral medicines or dietary supplements whose objective are to alleviate visual fatigue or symptoms of eye diseases
4. subjects who were considered inappropriate to participate in this study by physicians

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hidenaga Kobashi

Organization

Minamiaoyama Eye Clinic

Division name

Department of Ophthalmology

Zip code

Address

3-3-11 Kitaaoyama, Minato, Tokyo, Japan

TEL

03-5772-1451

Email

himon@hotmail.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroki Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code

Address

NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Minamiaoyama Eye Clinic

Institute

Department

Personal name

Organization

BALMUDA Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

07

Month

28

Day

Date of IRB

Anticipated trial start date

2018

Year

07

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

08

Month

20

Day

Last modified on

2019

Year

03

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038581