UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040952 |
|---|---|
| Receipt number | 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 22:45:09 |
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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
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
uchino.z2@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046763
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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