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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040952
Receipt No. R000046763
Scientific Title The research for the relationship between dry eye with corneal neuropathic pain and galectin-3 concentration in tear
Date of disclosure of the study information 2020/07/07
Last modified on 2020/06/29

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Basic information
Public title The research for the relationship between dry eye with corneal neuropathic pain and galectin-3 concentration in tear
Acronym The research for the relationship between dry eye with corneal neuropathic pain and galectin-3 concentration in tear
Scientific Title The research for the relationship between dry eye with corneal neuropathic pain and galectin-3 concentration in tear
Scientific Title:Acronym The research for the relationship between dry eye with corneal neuropathic pain and galectin-3 concentration in tear
Region
Japan

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

Objectives
Narrative objectives1 We measure the galectin-3 concentration in tears in dry eye patients, and clarify about the relationship between subjective symptoms, hyperalgesia, corneal neuropathy and the concentration of galectin-3 in tears
Basic objectives2 Others
Basic objectives -Others In addition to galectin-3 concentration, MUC5AC concentration and protein analysis are also performed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the galectin-3 concentration in tears
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Dry eye group
1. Those who plan to go to an ophthalmology outpatient in Keio University Hospital to be performed dry eye examination and medical treatment
2. Those who are 30 years old or older and have voluntarily agreed to their documents
3. No history of keratoconjunctival surgery within the past year
4. Dry eye patients diagnosed as dry eye that meet the dry eye diagnostic criteria
(Attachment) Dry eye diagnostic criteria 2016 version (Dry eye study group)
1) Subjective symptoms of dry eye such as eye discomfort and abnormal visual function
2) Tear break up time (BUT) is 5 seconds or less
A positive finding for all parameters was considered grounds for a positive diagnosis of dry eye.

Normal group
1.Those who wish to participate in the research as volunteers who are visiting the ophthalmology clinic
2. Those who are 30 years old or older and have voluntarily agreed to their documents
3. No history of keratoconjunctival surgery within the past year
4. Meets the conditions 1)-3) below parameters
1) There are no subjective symptoms of dry eye such as eye discomfort or visual dysfunction
2) BUT is 6 seconds or more
3) No keratoconjunctival epithelial disorder
Key exclusion criteria Exclude people who meet any of the following conditions from both dry eye group and control group
1. Those who do not agree with the ophthalmic examination
2. Those who do not consent to tear collection
3. Those who have a history of keratoconjunctival surgery within the past year
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuichi
Middle name
Last name Uchino
Organization Keio University Hospital
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi Shinjyuku-ku Tokyo Japan
TEL 03-3353-1211
Email uchino.z2@keio.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Uchino
Organization Keio University Hospital
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi Shinjyuku-ku Tokyo Japan
TEL 03-3353-1211
Homepage URL
Email uchino.z2@keio.jp

Sponsor
Institute Keio University
Institute
Department

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

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

IRB Contact (For public release)
Organization Keio University
Address 35 Shinanomachi Shinjyuku-ku Tokyo Japan
Tel 0333531211
Email uchino.z2@keio.jp

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
2020 Year 07 Month 07 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 18 Day
Date of IRB
2020 Year 03 Month 02 Day
Anticipated trial start date
2020 Year 07 Month 21 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Galectin-3 concentration in tear, Corneal neuropathic pain

Management information
Registered date
2020 Year 06 Month 29 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046763

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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