UMIN-CTR Clinical Trial

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
Email	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
Email	ophthalmolog1st.acek39@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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)
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040576