UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027958 |
|---|---|
| Receipt number | R000032008 |
| Scientific Title | The research for the association between mucins concentration in tear and severity of dry eye disease |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2021/01/01 23:32:47 |
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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
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
uchino.z2@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032008
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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