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Recruitment status Completed
Unique ID issued by UMIN UMIN000014704
Receipt No. R000016839
Scientific Title To investigate the effect of the humidity environment in a driving simulator on driving performance and visual function
Date of disclosure of the study information 2014/07/29
Last modified on 2016/04/09

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Basic information
Public title To investigate the effect of the humidity environment in a driving simulator on driving performance and visual function
Acronym To investigate the effect of the humidity environment in a driving simulator on driving performance and visual function
Scientific Title To investigate the effect of the humidity environment in a driving simulator on driving performance and visual function
Scientific Title:Acronym To investigate the effect of the humidity environment 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 ergonomic parameters(driving performance,blink rate, ECG, EMG,muscle hardness etc)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 moisturized environment
Interventions/Control_2 low-humidity environment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email motoko326@gmail.com

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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 07 Month 29 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 06 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 30 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 07 Month 29 Day
Last modified on
2016 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016839


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