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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001591
Receipt No. R000001911
Scientific Title Efficacy of eye washing after swimming in swimming pools
Date of disclosure of the study information 2008/12/19
Last modified on 2009/11/26

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Basic information
Public title Efficacy of eye washing after swimming in swimming pools
Acronym Efficacy of eye washing after swimming
Scientific Title Efficacy of eye washing after swimming in swimming pools
Scientific Title:Acronym Efficacy of eye washing after swimming
Region
Japan

Condition
Condition corneal epithelitis/corneal epithelial erosion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of wearing goggles during swimming and eye washing after swimming.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Severity of corneal epithelitis, anterior fluorometry, and confocal microscopy of the corneal epithelium will be assessed at before, immediately after, 1 day, 1 week and 2 weeks after the swimming.
Key secondary outcomes Visual acuity, intraocular pressure, refraction, corneal sensitivity, corneal topography, corneal pachymetry, and tear examination.

Base
Study type Interventional

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

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 wearing goggles during swimming, washing eyes after swimming
Interventions/Control_2 wearing goggles during swimming, instilling artificial tears after swimming
Interventions/Control_3 wearing goggles during swimming, no care after swimming
Interventions/Control_4 wearing no goggles during swimming, washing eyes after swimming
Interventions/Control_5 wearing no goggles during swimming, instilling artificial tears after swimming
Interventions/Control_6 wearing no goggles during swimming, no care after swimming
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 Age 20-60 years old
Those who does not have eye diseases or general diseases that may influence wound healing of the corneal epithelium.
Those who does not wear contact lenses, or who can stop to use contact lenses 1 week prior starting of the present study.
Those who has no history of corneal surgery within 1 year.
Those who can swim.
Key exclusion criteria Age less than 20 years old, or higher than 61 years old.
Those who has any eye diseases, such as dry eye, ocular allergy, acute infection, or glaucoma.
Those who has general diseases, such as diabetes.
Those who wears contact lenses.
Those who has a history of corneal surgery within 1 year.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Murat Dogru
Organization Keio University, School of Medicine
Division name Johnson & Johnson Ocular Surface Visual Optics Department
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University, School of Medicine
Division name Department of Ophthalmology
Zip code
Address
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2008 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 19 Day
Last modified on
2009 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001911

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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