UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationships of MMP and mucin density in dry eye patients
Title of the study (Brief title)	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	Yuichi Uchino
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL	03-5363-3821
Email	hmpgx653@yahoo.co.jp

Public contact
Name of contact person	Yuichi Uchino
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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