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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030216
Receipt No. R000034511
Scientific Title Evaluation of tear meniscus height with fluorescein staining
Date of disclosure of the study information 2017/12/01
Last modified on 2017/12/01

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Basic information
Public title Evaluation of tear meniscus height with fluorescein staining
Acronym Evaluation of tear meniscus height with fluorescein staining
Scientific Title Evaluation of tear meniscus height with fluorescein staining
Scientific Title:Acronym Evaluation of tear meniscus height with fluorescein staining
Region
Japan

Condition
Condition normal subjects
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Tear meniscus of subjects are stained with fluorescein, and image by DR-1a. Compare the normaly tear meniscus height by tear film specular reflection with the fluorescent tear meniscus height.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tear meniscus height
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 First, tear meniscus of subjects are stained with fluorescein and the tear meniscus image is recorded by illuminating with a white LED.
Next, the fluorescence is excited by switching the illumination light to blue LED and the fluorescent tear meniscus image is recorded.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria normal subjects (DEQS score is 6 or less)
Key exclusion criteria dry eye
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamauchi Takanori
Organization Kowa Company. Ltd.
Division name Medical Device Division
Zip code
Address 3-1, Chofugaoka 3-chome, Chohu, Tokyo JAPAN
TEL 042-440-7629
Email takanori-yamauchi@kowa.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kato Nakahiro
Organization Kowa Company. Ltd.
Division name Medical Device Division
Zip code
Address 3-1, Chofugaoka 3-chome, Chohu, Tokyo JAPAN
TEL 042-440-7629
Homepage URL
Email na-kato@kowa.co.jp

Sponsor
Institute Kowa Company. Ltd.
Institute
Department

Funding Source
Organization Itoh Clinic
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 伊藤医院(Itoh Clinic)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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
2017 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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