UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045398 |
|---|---|
| Receipt number | R000051839 |
| Scientific Title | Changes in tear film stability on the ocular surface when wearing facemask |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2022/10/24 18:49:33 |
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Basic information
Public title
Changes in tear film stability on the ocular surface when wearing facemask
Acronym
Changes in the ocular surface when wearing facemask
Scientific Title
Changes in tear film stability on the ocular surface when wearing facemask
Scientific Title:Acronym
Changes in the ocular surface when wearing facemask
Region
| Japan |
Condition
Condition
normal, dry eye
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate how the wind caused by leaking breath when wearing a mask affects the ocular surface temperature and blood flow.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tear film stability
ocular surface temperature
ocular anterior segment blood flow
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
| Other |
Interventions/Control_1
facemask
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
normal subjects
soft contact lens wearers
dry eye
Key exclusion criteria
Patients with eye diseases other than dry eye
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hori |
| Middle name | |
| Last name | Yuichi |
Organization
Toho university omori medical center
Division name
Ophthalmology
Zip code
143-8541
Address
6-11-1 Omori-Nishi, otaku, Tokyo
TEL
0337624151
yhori@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Itokawa |
| Middle name | |
| Last name | Takashi |
Organization
Toho university omori medical center
Division name
Ophthalmology
Zip code
143-8541
Address
6-11-1 Omori-Nishi, otaku, Tokyo
TEL
0337624151
Homepage URL
takashi.itokawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university omori medical center
Institute
Department
Personal name
Funding Source
Organization
Toho university omori medical center
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
Toho university omori medical center
Address
6-11-1 Omori-Nishi, otaku, Tokyo
Tel
0337624151
takashi.itokawa@med.toho-u.ac.jp
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
| 2021 | Year | 09 | Month | 07 | 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
60
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
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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