UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the association with dry eye syndrome and the periocular drying.
Title of the study (Brief title)	Lines study
Region	Japan

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

Objectives
Narrative objectives1	With an examination related to dry eye diagnosis and measuring the oil content and moisture of the skin around the eyes, the goal is to confirm the relationship between dry eye and dryness around the eyes.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of index and index about the dry skin about the dry eye syndrome.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with dry eye. 2)Patients who is between 20 and 60 years old. 3)Patients who provided written informed consent for participating in this study. 4)patients who is testable by the instructions such as researchers on an agreement acquisition day. 5)Male and Female 6)The contact lens use or nonuse doesn't matter.
Key exclusion criteria	1)Patients with the past of may have an influence on cornea and the tear, treating it surgically. 2)Skin treatment, patients ( include eye ointment, use of eye cream) who cares around the eyelid and the eyelid. 3)Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate. 4)Patients whom a study person in charge judged to be inappropriate to carry out this study safely
Target sample size	50

Research contact person
Name of lead principal investigator	Takashi Suzuki
Organization	Ishizuchi Eye Clnic
Division name	Director
Address	1-8-30 Shonaicyo Niihama-city Ehime
TEL	0898-33-3069
Email	t-suzuki@ishizuchi-eye-clinic.jp

Public contact
Name of contact person	Takashi Suzuki
Organization	Ishizuchi Eye Clnic
Division name	Director
Address	1-8-30 Shonaicyo Niihama-city Ehime
TEL	0898-33-3069
Homepage URL
Email	t-suzuki@ishizuchi-eye-clinic.jp

Sponsor
Institute	Ishizuchi Eye Clnic
Institute
Department

Funding Source
Organization	Menicon 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	2016 Year 11 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 13 Day
Anticipated trial start date	2016 Year 11 Month 14 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	None

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2017 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028527