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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026602
Receipt No. R000030542
Scientific Title A study on tear function tests using a novel tear absorbing strip (SMTube)
Date of disclosure of the study information 2017/06/01
Last modified on 2018/10/25

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Basic information
Public title A study on tear function tests using a novel tear absorbing strip (SMTube)
Acronym A study on tear function tests using a novel tear absorbing strip (SMTube)
Scientific Title A study on tear function tests using a novel tear absorbing strip (SMTube)
Scientific Title:Acronym A study on tear function tests using a novel tear absorbing strip (SMTube)
Region
Japan

Condition
Condition Dry Eye Disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, Echo Electricity Co., Ltd. has successfully developed and initiated a manufacture of Strip Meniscometry Tube (SMTube), which is a medical device used for quantification of the tear meniscus volume residing on the ocular surface. SMTube allows one to measure the tear meniscus volume with five seconds of the testing time for one eye, which is remarkably shorter compared to the conventional Schirmer test requiring five minutes of the testing time.
A clinical efficacy of SMTube has been previously reported, where the testing was performed by a medical doctor under the use of a slit lamp biomicroscopy system. However, the efficacy of SMTube is still unclear if performed by a technical staff in clinics. The objective of this study is to investigate the clinical performance of SMTube when the test is conducted by a technician.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SMTube testing
Meibomian Gland Dysfunction diagnosis
The Schirmer test
Tear film breakup time measurement
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 NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 SMTube testing (once)
MGD diagnosis (once)
BUT measurement (3 times)
The Schirmer test (once)
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
70 years-old >
Gender Male and Female
Key inclusion criteria N/A
Key exclusion criteria A decision should be made by a responsible doctor.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Miyasaka
Organization Echo Electricity Co Ltd
Division name R&D
Zip code
Address 6-24-14 Umeda, Adachi, Tokyo
TEL 03-3880-0455
Email kmfbus@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Okumura
Organization Mediproduce, Inc.
Division name Project Manager
Zip code
Address 2-26-35-8F Minami-Aoyama, Minato, Tokyo
TEL 03-5775-2075
Homepage URL
Email okumura@mediproduce.com

Sponsor
Institute Echo Electricity Co Ltd
Institute
Department

Funding Source
Organization Echo Electricity Co Ltd
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 羽根木の森アイクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 24 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 17 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030542

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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