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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003117
Receipt No. R000003746
Scientific Title Effect of eye washing with isotonic saline on ocular surface
Date of disclosure of the study information 2010/01/30
Last modified on 2010/07/30

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Basic information
Public title Effect of eye washing with isotonic saline on ocular surface
Acronym Effect of eye washing with isotonic saline
Scientific Title Effect of eye washing with isotonic saline on ocular surface
Scientific Title:Acronym Effect of eye washing with isotonic saline
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove that eye washing with isotonic saline is more safe to the ocular surface compare to washing with tap water.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire, visual acuity, slit lamp examination including vital staining for corneal and conjunctival epithelium, intraocular pressure, anterior fluorometry, in vivo confocal microscopy, corneal topography.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The volunteers will wash their eyes with isotonic saline for 30 seconds.
Interventions/Control_2 The volunteers will wash their eyes with tap water for 30 seconds.
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 Age; 20 to 60 years old.
Those who has no general diseases that could influence to the corneal wound healing.
Those who dose not wear contact lenses, or those who are able to interrupt wearing contact lenses from 3 days before the examination.
Those who have not undergone corneal surgery within 1 year before the examination.
Key exclusion criteria Age; under 20 years old, over 60 years old
Those who have ocular diseases, such as dry eye, allergic conjunctivitis, acute infection, glaucoma, etc.
Those who have general diseases, such as diabetis melitus.
Those who wear contact lenses and not be able to interrupt using them.
Those who underwent corneal surgery within 1 year.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tsubota
Organization Keio University School of Medicine
Division name Department of Ophthalmology
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 Naoko Kato
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo
TEL 03-5363-3972
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology
Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology
Keio University School of Medicine
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
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
2010 Year 01 Month 30 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 Completed
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 30 Day
Last modified on
2010 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003746

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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