UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the effect of the humidity environment in a driving simulator on driving performance and visual function
Title of the study (Brief title)	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	Motoko Kawashima
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	81333531211
Email	motoko326@gmail.com

Public contact
Name of contact person	Motoko Kawashima
Organization	Keio University School of Medicine
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000016839