UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-blind, randomized controlled trial to assess the effect of blue-light alleviation on visual fatigue in healthy volunteers
Title of the study (Brief title)	Single-blind, randomized controlled trial to assess the effect of blue-light alleviation on visual fatigue in healthy volunteers
Region	Japan

Condition
Condition	healthy volunteers
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Hidenaga Kobashi
Organization	Minamiaoyama Eye Clinic
Division name	Department of Ophthalmology
Address	3-3-11 Kitaaoyama, Minato, Tokyo, Japan
TEL	03-5772-1451
Email	himon@hotmail.co.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Minamiaoyama Eye Clinic
Institute
Department

Funding Source
Organization	BALMUDA 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	2018 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 28 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038581