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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028550
Receipt No. R000032677
Scientific Title Comparison of measurement value of tear meniscus between by DR1a and CASIA2
Date of disclosure of the study information 2017/08/05
Last modified on 2018/03/16

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Basic information
Public title Comparison of measurement value of tear meniscus between by DR1a and CASIA2
Acronym Measurement of tear meniscus by DR1a and CASIA2
Scientific Title Comparison of measurement value of tear meniscus between by DR1a and CASIA2
Scientific Title:Acronym Measurement of tear meniscus by DR1a and CASIA2
Region
Japan

Condition
Condition normal subjects and dry eye patients
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the coincidence of the measurement value by DR1a abd by CASIA2 in normal subjects and dry eye patients
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tear meniscus height
eyelid findings
tear breakup time
Schirmer's test value
Key secondary outcomes

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
85 years-old >=
Gender Male and Female
Key inclusion criteria subjects whose written informed consentis obtained
Key exclusion criteria patients suffered from ocular diseases
patients with injury, swelling or eczema around eye or eylids
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic
Division name Ophthalmology
Zip code
Address 626-11 Minaminakano, minuma-ku, Saitama, Saitama
TEL 048-686-5588
Email arita.reiko@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic
Division name Ophthalmology
Zip code
Address 626-11 Minaminakano, minuma-ku, Saitama, Saitama
TEL 048-686-5588
Homepage URL
Email arita.reiko@gmail.com

Sponsor
Institute Itoh Clinic
Institute
Department

Funding Source
Organization Itoh Clinic
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 08 Month 05 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032677

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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