UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035618 |
|---|---|
| Receipt number | R000040576 |
| Scientific Title | Analysis of an association between dry eye and ocular surface and intestinlal microbiome |
| Date of disclosure of the study information | 2019/01/22 |
| Last modified on | 2021/02/05 17:42:19 |
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Basic information
Public title
Analysis of an association between dry eye and ocular surface and intestinlal microbiome
Acronym
Dry eye and microbiome
Scientific Title
Analysis of an association between dry eye and ocular surface and intestinlal microbiome
Scientific Title:Acronym
Dry eye and microbiome
Region
| Japan |
Condition
Condition
Chronic graft-versus-host disease (GVHD)-related dry eye disease after hematopoietic stem cell transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the exploitary analysis on the changes of ocular surface and intestinal microbiome with or without chronic graft-versus-host disease (GVHD)-related dry eye disease after hamatopoietic stem cell transplantation(HSCT).
Basic objectives2
Others
Basic objectives -Others
To explore the differences of ocular surface and intestinal microbiome with or without chronic GVHD-related dry eye disease. To explore the relationship between the changes of ocular surface and intestinal microbiome and the severity of chronic GVHD-related dry eye disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characterization of microbiota for chronic GVHD-related dry eye disease compared with the controls.
Key secondary outcomes
Functional expectation of ocular surface and intestinal microbiome depending on the severity of chronic GVHD-related dry eye disease.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adult over 20 years old who is attending dry eye clinic at Keio University Hospital
2) Written informed consent
3) Patients who have newly developed dry eye disease (i.e. chronic GVHD-related dry eye disease) after hematopoietic stem cell transplantation (HSCT).
4) Patients who did not develop dry eye disease after HSCT.
5) Patients who did not have dry eye disease before HSCT.
Eligible for the patients who can be recruited is to fulfill the above number of 1) 2)3)or 1)2)4) or 1)2)5)
Diagnostic criteria for dry eye by Japanese Dry Eye Society 2006
Key exclusion criteria
1) No written informed consent
2) No other autoimmune disease
3) No allergic conjunctivitis, ocular surface infectious disease, nor contact lens wearer
4) No dry eye disease before hematopietic stem cell transplantation
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shimizu |
| Middle name | |
| Last name | Eisuke |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, Japan
TEL
0353633972
ophthalmolog1st.acek39@keio.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Shimizu |
Organization
Keio University Schol of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo, 160-8582, Japan
TEL
0353633972
Homepage URL
ophthalmolog1st.acek39@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JKiC (JSR and Keio University Medicine and Chemistry Innovation Center) Academic Study Developing Project
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
Ethical committee Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-3353-1211(62014)
med-rinri-jimu@adst.keio.ac.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
| 2019 | Year | 01 | Month | 22 | 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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Shirmer test, Conreal sensitivity, tear clearence, fluorescein staining, Lissamin green staining, tear film break up time, questionnaire for symptom (ocular surface disease index (OSDI))
2) Visual acuity, ocular tension, refraction, length of eye, vitoreoretinal abnormality according to routine examination for eye.
3) Impression cytology and brush cytology for conjunctiva
4) Stool
5) Medical history
6) Researcher will analyse the above mentioned examinations.
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040576
