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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033240
Receipt No. R000037812
Scientific Title Effect on accommodation and dry eyes in sports
Date of disclosure of the study information 2018/07/02
Last modified on 2019/07/08

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Basic information
Public title Effect on accommodation and dry eyes in sports
Acronym Effect on accommodation and dry eyes in sports
Scientific Title Effect on accommodation and dry eyes in sports
Scientific Title:Acronym Effect on accommodation and dry eyes in sports
Region
Japan

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

Objectives
Narrative objectives1 To clarify the effect on accommodation and dry eye in sports.
Basic objectives2 Others
Basic objectives -Others We investigate the effect of eye drop to the reduction of accommodation and dry eye symptoms during sports.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes accommodation
Key secondary outcomes Subjective symptoms of dry eye by the Dry Eye-Related Quality-of-Life Score Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 eye drop group
Interventions/Control_2 non-eye drop 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)The individual has signed a written consent form for this research
(2)Over 20 years old at the time of the obtained consent form
Key exclusion criteria Participants who are diagnosed to be inappropriate for this research by the physician in charge of implementing this research.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takenori
Middle name
Last name Inomata
Organization Juntendo University Faculty of medicine
Division name Ophthalmology
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email tinoma@juntendo.ac.jp

Public contact
Name of contact person
1st name Takenori
Middle name
Last name Inomata
Organization Juntendo University Faculty of medicine
Division name Ophthalmology
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email tinoma@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo 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 Juntendo Clinical Research and Trial Center
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-3813-3111
Email kenkyu5858@juntendo.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
2018 Year 07 Month 02 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 22 Day
Date of IRB
2017 Year 08 Month 09 Day
Anticipated trial start date
2017 Year 09 Month 22 Day
Last follow-up date
2020 Year 03 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
2018 Year 07 Month 02 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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