UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of tear volume change by abdominal breathing in dry eye disease patients
Title of the study (Brief title)	Evaluation of tear volume change by abdominal breathing in dry eye disease patients
Region	Japan

Condition
Condition	dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the change of tear volume by parasympathetic effect with abdominal breathing for dry eye disease patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Strip tear Meniscometry value heart rate variability body temperature around eye tear film break-up time tear meniscus height DEQS QIDS-J
Key secondary outcomes

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	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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	behavior intervention
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

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 provided written consent form on their voluntary basis People who were diagnosed as dry eye disease
Key exclusion criteria	People who didn't provid written consent form People who couldn't do abdominal breathing by some reason Pregnant women
Target sample size	30

Research contact person
Name of lead principal investigator	Motoko Kawashima
Organization	Keio University School of Medicine
Division name	Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3866
Email	motoko-k@a3.keio.jp

Public contact
Name of contact person	Kokoro Sano
Organization	Keio University School of Medicine
Division name	Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3866
Homepage URL
Email	kokoro.sano@keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Ophthalmology
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	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2015 Year 06 Month 22 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 12 Month 22 Day
Anticipated trial start date	2015 Year 06 Month 22 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	2015 Year 06 Month 22 Day
Last modified on	2016 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020885