UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001591 |
|---|---|
| Receipt number | 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 15:02:26 |
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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
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
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001911
