UMIN-CTR Clinical Trial

Basic information
Public title	The research for the association between mucins concentration in tear and severity of dry eye disease
Acronym	The research for the association between mucins concentration in tear and severity of dry eye disease
Scientific Title	The research for the association between mucins concentration in tear and severity of dry eye disease
Scientific Title:Acronym	The research for the association between mucins concentration in tear and severity of dry eye disease
Region	Japan

Condition
Condition	dry eye disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify about the association between mucins concentration in tear and five types of tear break up patterns in dry eye disease.
Basic objectives2	Others
Basic objectives -Others	To clarify about the association between mucins concentration in tear and dry eye symptoms in dry eye disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	concentration of mucins in tear
Key secondary outcomes

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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Thirty years of age or older, and those whose informed consent was obtained by his / her own will. 2. Those do not have the eye disease and systemic disease including Diabetes. 3. Without history of keratoconjunctival surgery within the past year 4. Dry eye patients diagnosed by Japanese dry eye diagnosis criteria in 2006
Key exclusion criteria	1. Those that can not obtain informed consent for ophthalmic examination. 2. Those that can not obtain informed consent for tear collection. 3. Those taking supplements such as vitamins. 4. With history of keratoconjunctival surgery within the past year.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuichi Uchino
Organization	Keio University Hospital
Division name	Department of Ophthalmology
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo
TEL	03-3353-1211
Email	uchino.z2@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichi Uchino
Organization	Keio University Hospital
Division name	Department of Ophthalmology
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo
TEL	03-3353-1211
Homepage URL
Email	uchino.z2@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 06 Month 28 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	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 02 Day
Date of IRB	2017 Year 10 Month 03 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	concentration of mucins in tear, tear film break pattern

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2021 Year 01 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032008