UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030216 |
|---|---|
| Receipt number | R000034511 |
| Scientific Title | Evaluation of tear meniscus height with fluorescein staining |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2020/12/17 13:11:45 |
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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
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
na-kato@kowa.co.jp
Sponsor or person
Institute
Kowa Company. Ltd.
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 14 | Day |
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
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034511
