UMIN-CTR Clinical Trial

Basic information
Public title	Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Acronym	Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Scientific Title	Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Scientific Title:Acronym	Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Region	Japan

Condition
Condition	ocular disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Biomarkers, which are indicators for objectively measuring and evaluating the physical condition of a human being, are generally made possible by blood collection and urine collection. In eye diseases, tears can be collected relatively easily, so if biomarkers in tears can be found, diagnosis can be made further non-invasively. In this study, we will analyze lipids contained in tears for the discovery of new biomarkers in eye diseases such as eye infections, eye tumors and eye allergy (lipidome analysis). We believe that biomarkers in the tears, as revealed by this study, will allow for a more non-invasive diagnosis of eye disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The tears are collected with Schirmer's test paper for 5 minutes from patients who obtained informed consent at the visit to the outpatient clinic, and then comprehensive concentration measurement of extracted lipids is performed using a mass spectrometer
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	At the time of outpatient visit, tears are collected for 5 minutes in Schirmer test.
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	18 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	anterior segment disease
Key exclusion criteria	History of eyedrops treatment History of eyesurgery
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name YUKINOBU Middle name Last name OKAJIMA
Organization	Toho University omori medical center
Division name	Opthalmology
Zip code	143-8451
Address	6-11-1 omorinishi ootaku tokyo
TEL	03-3762-4151
Email	yukinobu.okajima@med.toho-u.ac.jp

Public contact
1st name of contact person	1st name YUKINOBU Middle name Last name OKAJIMA
Organization	Toho University omori medical center
Division name	Opthalmology
Zip code	143-8451
Address	6-11-1 omorinishi ootaku tokyo
TEL	03-3762-4151
Homepage URL
Email	yukinobu.okajima@med.toho-u.ac.jp

Sponsor
Institute	Toho University omori medical center
Institute
Department

Funding Source
Organization	Toho University omori medical center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toho University omori medical center
Address	6-11-1 omorinishi ootaku tokyo
Tel	03-3762-4151
Email	yukinobu.okajima@med.toho-u.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 03 Month 18 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	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 18 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041289