UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of rebamipide in soft contact lens patients with dry eyes.
Title of the study (Brief title)	Effect of rebamipide in soft contact lens patients with dry eyes.
Region	Japan

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

Objectives
Narrative objectives1	We examined subjective symptoms, objective signs and inflammatory cytokines for dry eye patients with contact lens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	subjective symptoms after 1 month
Key secondary outcomes	Examination of dry eye

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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eye drop of rebamipide 1 month 4 times per a day
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	Dry eye patient with soft contact lens.
Key exclusion criteria	Patient with drug allergy. Patient with allergic conjunctivitis or allergic rhinitis. Patient with more than 2 points for examination of corneal fluorescein staining score.
Target sample size	20

Research contact person
Name of lead principal investigator	Tsutomu Igarashi
Organization	Nippon medical school hospital
Division name	Ophthalmology
Address	1-1-5 Sendagi, Bunkyoku, Tokyo
TEL	03-3822-2131
Email	tutomu@nms.ac.jp

Public contact
Name of contact person	Tsutomu Igarashi
Organization	Nippon Medical School Hospital
Division name	Ophthalmology
Address	1-1-5 Sendagi, Bunkyoku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	tutomu@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
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	Yaguchi Eye Clinic
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 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 09 Day
Anticipated trial start date	2015 Year 11 Month 11 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 11 Month 10 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022781