UMIN-CTR Clinical Trial

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