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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030625
Receipt No. R000034957
Scientific Title Relationships of MMP and mucin density in dry eye patients
Date of disclosure of the study information 2018/01/08
Last modified on 2018/12/10

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Basic information
Public title Relationships of MMP and mucin density in dry eye patients
Acronym Relationships of MMP and mucin density in dry eye patients
Scientific Title Relationships of MMP and mucin density in dry eye patients
Scientific Title:Acronym Relationships of MMP and mucin density in dry eye patients
Region
Japan

Condition
Condition Dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure mucin and MMP concentration in tear of dry eye patients and clarify the association between the mucin concentration and subjective symptoms or ocular surface condition using a tear mucin measurement kit.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mucin concentration
Key secondary outcomes MMP concentration, inflammatry proteins concentration

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Person who visit a hospital for treatment in the ophthalmology clinic and undergo inspection of the dry eye syndrome and medical treatment.

2. Person in more than 30 years old who agree with the informed consent.

3.Person who do not have any systemic disease influenced on the wound healing of eye diseases or diabetes.

4. Person who did not have any keratoconjunctive operation within the past one year.
Key exclusion criteria 1. Person who do not agree with eye exams.

2. Person who do not agree with tear collection by Schirmer test.

3.Person who take the supplements such as vitamins.

4.Preson who underwent keratoconjunctiva operation within the past one year.

5.Smokers
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Uchino
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL 03-5363-3821
Email hmpgx653@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Uchino
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL 03-5363-3821
Homepage URL
Email hmpgx653@yahoo.co.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 01 Month 08 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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 We collect and cryopreserve the schirmer test paper and examine relationship between mucin, MMP and inflammatory protein cocentration and the severity of dry eye syndrome.

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034957

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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