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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013221
Receipt No. R000015430
Scientific Title Examination of the safety of hydrogen eye drop
Date of disclosure of the study information 2014/02/22
Last modified on 2014/08/22

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Basic information
Public title Examination of the safety of hydrogen eye drop
Acronym Examination of the safety of hydrogen eye drop
Scientific Title Examination of the safety of hydrogen eye drop
Scientific Title:Acronym Examination of the safety of hydrogen eye drop
Region
Japan

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

Objectives
Narrative objectives1 Examination of the safety of hydrogen eye drop
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes eye examination
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 hydrogen
Interventions/Control_2 saline solution
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

Not applicable
Gender Male and Female
Key inclusion criteria normal
Key exclusion criteria eye disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Igarashi
Organization Nippon Medical School Hospital
Division name Ophthalmology
Zip code
Address 1-1-5 Sendagi, Bunkyoku, Tokyo
TEL 03-3822-2131
Email tutomu@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonaga Takase
Organization Nippon Medical School Hospital
Division name IRB
Zip code
Address 1-1-5 Sendagi, Bunkyoku, Tokyo
TEL 03-3822-2131
Homepage URL
Email clinicaltrial@nms.ac.jp

Sponsor
Institute Ophthalmology, Nippon Medical school
Institute
Department

Funding Source
Organization Ophthalmology, Nippon Medical school
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 02 Month 22 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 01 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 22 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 02 Month 22 Day
Last modified on
2014 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015430

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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