UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015535 |
|---|---|
| Receipt number | R000018048 |
| Scientific Title | To investigate the effect of the humidifying device in a driving simulator on driving performance and visual function |
| Date of disclosure of the study information | 2014/10/27 |
| Last modified on | 2016/04/09 16:43:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
To investigate the effect of the humidifying device in a driving simulator on driving performance and visual function
Acronym
To investigate the effect of the humidifying device in a driving simulator on driving performance and visual function
Scientific Title
To investigate the effect of the humidifying device in a driving simulator on driving performance and visual function
Scientific Title:Acronym
To investigate the effect of the humidifying device in a driving simulator on driving performance and visual function
Region
| Japan |
Condition
Condition
dry eye/Healthy volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the humidified environment on dry eye and fatigue assosiated with driving
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular surface parameters (symptoms,BUT, Fluorescein staining score, tear meniscus volume, functional visual acuity, CFF)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
humidifying device(+)
Interventions/Control_2
humidifying device(-)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
people who drive more then once a week
Key exclusion criteria
claustrophobic patient
patients who is under treatment of orthopedic or ocular diseases
contact lens wearers during experiment
people who have an allergy against alcohol or surgical tapes
people with a history of epilepsia
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
81333531211
motoko326@gmail.com
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
81333531211(63954)
Homepage URL
motoko326@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
DENSO CORPORATION
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
| 2014 | Year | 10 | Month | 27 | 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
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 27 | 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
| 2014 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018048
