UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030041 |
|---|---|
| Receipt number | R000034301 |
| Scientific Title | sensibility evaluation among different lighting condition |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2018/10/31 09:11:30 |
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Basic information
Public title
sensibility evaluation among different lighting condition
Acronym
sensibility evaluation among different lighting condition
Scientific Title
sensibility evaluation among different lighting condition
Scientific Title:Acronym
sensibility evaluation among different lighting condition
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which lighting condition is comfortable among glare light and 2 kinds
of glare-less light.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain wave
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
normal lighting
Interventions/Control_2
glare-less lighting 1
Interventions/Control_3
glare-less lighting 2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
1.participants who are currently under treatment of eye disease
2.participants who have brain disease (such as dementia and epilepsia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Keio University School of Mdeicine
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3972
motoko-k@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3972
Homepage URL
motoko-k@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
ModuleX Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 20 | 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 | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034301
