UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003117 |
|---|---|
| Receipt number | 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 14:44:15 |
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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
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
Sponsor or person
Institute
Department of Ophthalmology
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003746
