UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030625 |
|---|---|
| Receipt number | R000034957 |
| Scientific Title | Relationships of MMP and mucin density in dry eye patients |
| Date of disclosure of the study information | 2018/01/08 |
| Last modified on | 2018/12/10 12:37:47 |
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Basic information
Public title
Relationships of MMP and mucin density in dry eye patients
Acronym
Relationships of MMP and mucin density in dry eye patients
Scientific Title
Relationships of MMP and mucin density in dry eye patients
Scientific Title:Acronym
Relationships of MMP and mucin density in dry eye patients
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure mucin and MMP concentration in tear of dry eye patients and clarify the association between the mucin concentration and subjective symptoms or ocular surface condition using a tear mucin measurement kit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mucin concentration
Key secondary outcomes
MMP concentration, inflammatry proteins concentration
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
1. Person who visit a hospital for treatment in the ophthalmology clinic and undergo inspection of the dry eye syndrome and medical treatment.
2. Person in more than 30 years old who agree with the informed consent.
3.Person who do not have any systemic disease influenced on the wound healing of eye diseases or diabetes.
4. Person who did not have any keratoconjunctive operation within the past one year.
Key exclusion criteria
1. Person who do not agree with eye exams.
2. Person who do not agree with tear collection by Schirmer test.
3.Person who take the supplements such as vitamins.
4.Preson who underwent keratoconjunctiva operation within the past one year.
5.Smokers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Uchino |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL
03-5363-3821
hmpgx653@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Uchino |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL
03-5363-3821
Homepage URL
hmpgx653@yahoo.co.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
Japan
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
| 2018 | Year | 01 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect and cryopreserve the schirmer test paper and examine relationship between mucin, MMP and inflammatory protein cocentration and the severity of dry eye syndrome.
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034957
