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

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 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


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

Value
https://center6.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