UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034516
Receipt No. R000039250
Scientific Title The effect of a commercial eye wash solution on the ocular surface mucin layer
Date of disclosure of the study information 2018/10/25
Last modified on 2018/10/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of a commercial eye wash solution on the ocular surface mucin layer
Acronym The effect of a commercial eye wash solution on the ocular surface mucin layer
Scientific Title The effect of a commercial eye wash solution on the ocular surface mucin layer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Fujishima
Organization Tsurumi University School of Dental Medicine
Division name Department of Ophthalmology
Zip code
Address 2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan.
TEL 045-580-8599
Email fujishima117@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Fujishima
Organization Tsurumi University School of Dental Medicine
Division name Department of Ophthalmology
Zip code
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)

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
2018 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 72nd annual congress of japan clinical opthhalmology(2018)
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
2017 Year 09 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.