UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026602 |
|---|---|
| Receipt number | 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 | 2023/03/22 18:46:52 |
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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 | Keiichi |
| Middle name | |
| Last name | Miyasaka |
Organization
Echo Electricity Co Ltd
Division name
R&D
Zip code
1230851
Address
6-24-14 Umeda, Adachi, Tokyo
TEL
03-3880-0455
kmfbus@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Okumura |
Organization
Mediproduce, Inc.
Division name
Project Manager
Zip code
1070062
Address
2-26-35-8F Minami-Aoyama, Minato, Tokyo
TEL
03-5775-2075
Homepage URL
okumura@mediproduce.com
Sponsor or person
Institute
Echo Electricity Co Ltd
Institute
Department
Personal name
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
Haneginomori eye clinic
Address
4-26-4 Daita, Setagaya, Tokyo
Tel
03-6265-8777
mail@hanegi-eye.com
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
http://www.echo-mf.jp/en.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.echo-mf.jp/en.html
Number of participants that the trial has enrolled
23
Results
Preliminary data analyses on the test results are currently ongoing.
Results date posted
| 2020 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Outpatients to the clinic
Participant flow
The procedure was given upon the reception.
Adverse events
None
Outcome measures
- Descriptive statistics on test scores
- Correlations among the test results
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 23 | 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
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030542
| Research Plan | |
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| Registered date | File name |
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