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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018895
Receipt No. R000021868
Scientific Title Effect of multi supplement on subjects with dry eye symptoms
Date of disclosure of the study information 2015/09/03
Last modified on 2017/01/30

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Basic information
Public title Effect of multi supplement on subjects with dry eye symptoms
Acronym Effect of multi supplement on dry eye symptoms
Scientific Title Effect of multi supplement on subjects with dry eye symptoms
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo Tsubota
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211(62402)
Email tsubota@z3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Yamada
Organization Tsubota-lab
Division name Director
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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