UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014447
Receipt No. R000016810
Scientific Title Effect of multi supplement on Dry Eye Syndrome
Date of disclosure of the study information 2014/07/03
Last modified on 2015/07/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of multi supplement on Dry Eye Syndrome
Acronym Effect of multi supplement on Dry Eye Syndrome
Scientific Title Effect of multi supplement on Dry Eye Syndrome
Scientific Title:Acronym Effect of multi supplement on Dry Eye Syndrome
Region
Japan

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

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

Assessment
Primary outcomes dry eye symptom
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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
Interventions/Control_2 placebo
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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tsuboa
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 dry eye KT
Division name Director
Zip code
Address 4F Rune Aoyama, 3-3-11, Kitaaoyama, Minato-ku, Tokyo, Japan
TEL 03-6830-0731
Homepage URL
Email yamada@dryeye-kt.com

Sponsor
Institute dry eye KT
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 羽根木の森アイクリニック

Other administrative information
Date of disclosure of the study information
2014 Year 07 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
2014 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 14 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
2014 Year 07 Month 01 Day
Last modified on
2015 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016810

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.