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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017018
Receipt No. R000019738
Scientific Title Determination of the contamination of contact lenses and their cases.
Date of disclosure of the study information 2015/07/01
Last modified on 2017/12/12

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Basic information
Public title Determination of the contamination of contact lenses and their cases.
Acronym Determination of the contamination of contact lenses and their cases.
Scientific Title Determination of the contamination of contact lenses and their cases.
Scientific Title:Acronym Determination of the contamination of contact lenses and their cases.
Region
Japan

Condition
Condition Corneal infection and allergic conjunctivitis in contact lens users.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Contact lenses and their cases are contaminted with bacteria or proteins, that will cause ocular disorders. In the present study we determine the factors related to the contamination of contact lens and lens cases.
Basic objectives2 Others
Basic objectives -Others We determine the bacteria and proteins on contact lenses or lens cases.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We determine the bacteria and proteins on contact lenses or lens cases.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Contact lens users with corneal infection and allergic conjunctivitis.
Contact lens uses in whom the contamination of lens and lens cases are suspected.
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Kaji
Organization Tsukuba University
Division name Ophthalmology
Zip code
Address 1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL 0298533148
Email kajiyuichi@gmai.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Kaji
Organization Tsukuba University
Division name Ophthalmology
Zip code
Address 1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL 0298533148
Homepage URL
Email kajiyuichi@gmai.com

Sponsor
Institute Tsukuba University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 01 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 Preinitiation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2018 Year 07 Month 01 Day
Date of closure to data entry
2018 Year 07 Month 01 Day
Date trial data considered complete
2018 Year 07 Month 01 Day
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information Determination of the contamination of contact lenses and their cases.

Management information
Registered date
2015 Year 04 Month 02 Day
Last modified on
2017 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019738

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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