UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of rebamipide ophthalmic solution on dry eye among taxi drivers
Title of the study (Brief title)	Effect of rebamipide ophthalmic solution on dry eye among taxi drivers
Region	Japan

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

Objectives
Narrative objectives1	To investigate the treatment efficacy of rebamipide on dry eye in taxi drivers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fluorescein staining score, Symptoms Tear film breakup time(BUT)
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	Parallel
Randomization	Non-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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rebamipide ophthalmic solution
Interventions/Control_2	Non treatment
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	20 years-old <= taxi drivers
Key exclusion criteria	Patients with ocualr surface diseses except dry eye People use eyedrops including anti-glaucoma drops during the study Patients wearing contact lens during the study Patients who had punctal plug within 3 months or had punctal occlusion surgery Patients with a history of ocular surface surgery within 12 months or intraocular surgery within 3 months before the study Patients with ocular pemphigoid, and Stevens-Johnson syndrome People whom the investigator or the subinvestigators consider to be ineligible for the study judging from their medical history or general condition People whom the investigator or the subinvestigators consider to be ineligible for the study in any other reason
Target sample size	70

Research contact person
Name of lead principal investigator	Motoko Kawashima
Organization	Haneginomori eye clinic
Division name	Department of Ophthalmology
Address	4-26-4, Daita, Setagayaku, Tokyo 155-0033 Japan
TEL	03-6265-8777
Email	1test@testtest.co.jp

Public contact
Name of contact person	Yasunori Tomita
Organization	QOL RD Co.,Ltd
Division name	EBM Division
Address	Front Place Nihonbashi Bldg. 2-14-1, Nohonbashi, Chuo-ku, Tokyo 103-0027 Japan
TEL	03-6386-2642
Homepage URL
Email	2test@testtest.co.jp

Sponsor
Institute	Haneginomori eye clinic
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	Otsuka Pharmaceutical Co.,Ltd
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 08 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 26 Day
Anticipated trial start date	2014 Year 08 Month 21 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 08 Month 08 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=R000017211