UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effects of listening to music during desk work on the eyes
Acronym	A study of the effects of listening to music during desk work on the eyes
Scientific Title	A retrospective observational study of the effects of listening to music during desk work on the eyes
Scientific Title:Acronym	A retrospective observational study of the effects of listening to music during desk work on the eyes
Region	Japan

Condition
Condition	-
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Studying of the effects of listening to music on the eyes
Basic objectives2	Others
Basic objectives -Others	Elucidate effects
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective symptoms (eye strain, uncomfortable sensation, dry sensation, heavy sensation, sensitivity to bright light) obtained from questionnaire analysis
Key secondary outcomes	Tear volume obtained from anterior eye image analysis

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Males and Females in their 20s to 50s who are engaged in desk work such as computer work on a daily basis 2) Those who agree to aggregate, analyze, and publish the acquired data
Key exclusion criteria	Those who go to the hospital because of eye diseases
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Miyano
Organization	ROHTO PHARMACEUTICAL CO.,LTD.
Division name	Pharmaceutical & Device Development Division
Zip code	619-0216
Address	6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL	0774-71-8836
Email	miyano@rohto.co.jp

Public contact
Name of contact person	1st name Akinori Middle name Last name Nishimoto
Organization	ROHTO PHARMACEUTICAL CO.,LTD.
Division name	Pharmaceutical & Device Development Division
Zip code	619-0216
Address	6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL	0774-71-8836
Homepage URL
Email	nishimotoa@rohto.co.jp

Sponsor
Institute	ROHTO PHARMACEUTICAL CO.,LTD.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiba Palace Clinic Ethics Review Committee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel	03-5408-1590
Email	y_huzita@mail.souken-r.com

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	2022 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://usen.com/newsrelease/?type=info&year=2022&id=34508
Number of participants that the trial has enrolled	10
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	2021 Year 12 Month 28 Day
Date of IRB	2022 Year 01 Month 13 Day
Anticipated trial start date	2022 Year 02 Month 10 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Studying of the effects of listening to music on the eyes

Management information
Registered date	2022 Year 02 Month 01 Day
Last modified on	2022 Year 03 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053382