UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of multi supplement on subjects with dry eye symptoms
Title of the study (Brief title)	Effect of multi supplement on dry eye symptoms
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of multi supplement on subjects with dry eye symptoms
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dry eye parameter(Tear film break-up time(BUT),Strip meniscometry,Schirmer1 test,Symptoms(DEQS,VAS))
Key secondary outcomes	The grading of corneal and conjunctival staining,meibomian gland evaluation,8-OHdG in blood,HEL in blood

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	multisupplement(3 months)
Interventions/Control_2	placebo(3 months)
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	people who have dry eye symptom
Key exclusion criteria	People with active eye diseases except dry eye disease Patients who take any supplements. Patients with serious systemic diseases People whom the investigator or the subinvestigators consider to be ineligible for the intervention therapy in any other reason pregnant woman
Target sample size	80

Research contact person
Name of lead principal investigator	Kazuo Tsubota
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211(62402)
Email	tsubota@z3.keio.jp

Public contact
Name of contact person	Shintaro Yamada
Organization	Tsubota-lab
Division name	Director
Address	8F Aoyama KK, 2-26-35, Minamiaoyama, Minato-ku, Tokyo, Japan
TEL	03-6804-5888
Homepage URL
Email	inquiry_@_tsubota-lab.com

Sponsor
Institute	Tsubota-lab
Institute
Department

Funding Source
Organization	WAKAMOTO 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	2015 Year 09 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 04 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 09 Month 02 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021868