UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of a commercial eye wash solution on the ocular surface mucin layer
Title of the study (Brief title)	The effect of a commercial eye wash solution on the ocular surface mucin layer
Region	Japan

Condition
Condition	normal subjects
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of the corneal epithelium and ocular surface mucins after one month use of a commercial preservative free eye wash solution
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mRNA expressions of MUC5AC and MUC16
Key secondary outcomes	1.Dry Eye-related Quality of life Score (DEQS) 2.Tear film break-up time(BUT) 3.Corneal epithelial damage 4.Microflora analysis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	A commercial eye wash solution(Eyebon w)was used for monocular eye wash.
Interventions/Control_2	no treatment
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	1.Patients not using contact lenses. 2.Patients who had ocular surgery before the last six months. 3.patients who understands the contents of the consent document and is able to consent in the document of the person.
Key exclusion criteria	1.Patients who have any disease. conjunctival injection dry eye symptoms corneal epithelial damage 2.Patients who take current medications during the past one month . 3.Patients using contact lenses. 4.Patients judged by other research managers or researchers as inappropriate to implement this research safely.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Fujishima
Organization	Tsurumi University School of Dental Medicine
Division name	Department of Ophthalmology
Address	2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL	045-580-8599
Email	fujishima117@gmail.com

Public contact
Name of contact person	Hiroshi Fujishima
Organization	Tsurumi University School of Dental Medicine
Division name	Department of Ophthalmology
Address	2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL	045-580-8599
Homepage URL
Email	fujishima117@gmail.com

Sponsor
Institute	Tsurumi University
Institute
Department

Funding Source
Organization	Kobayashi International Scholarship Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	2018 Year 10 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 30 Day
Anticipated trial start date	2017 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	The 72nd annual congress of japan clinical opthhalmology(2018)
Other related information

Management information
Registered date	2018 Year 10 Month 16 Day
Last modified on	2018 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039250