UMIN-CTR Clinical Trial

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 Yuichi Middle name Last name Kaji
Organization	Tsukuba University
Division name	Ophthalmology
Zip code	3050006
Address	1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL	0298533148
Email	kajiyuichi@gmai.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Kaji
Organization	Tsukuba University
Division name	Ophthalmology
Zip code	3050006
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	Tsukuba Univ
Address	Tennoudai 1-1-1
Tel	0298533148
Email	kajiyuichi@gmail.com

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	2020 Year 12 Month 10 Day

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