UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017018 |
|---|---|
| Receipt number | 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 | 2020/12/10 21:34:58 |
* 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
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
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
kajiyuichi@gmai.com
Sponsor or person
Institute
Tsukuba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019738
