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

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 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)

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name