UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017019 |
|---|---|
| Receipt number | R000019739 |
| Scientific Title | Topical application of polyhexamethylene biguanide on Acanthamoeba keratitis. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2020/12/10 21:36:24 |
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Basic information
Public title
Topical application of polyhexamethylene biguanide on Acanthamoeba keratitis.
Acronym
Topical application of polyhexamethylene biguanide on Acanthamoeba keratitis.
Scientific Title
Topical application of polyhexamethylene biguanide on Acanthamoeba keratitis.
Scientific Title:Acronym
Topical application of polyhexamethylene biguanide on Acanthamoeba keratitis.
Region
| Japan |
Condition
Condition
Acanthamoeba keratitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
No commercialized drugs exist to treat Acanthamoeba keratitis. However, topical application of polyhexamethylene biguanide is reported to be effective on Acanthamoeba keratitis, and now recognized as a first-choice drug worldwide. In the present study, we would like to treat Acanthamoeba keratitis with topocal application of polyhexamehtylene biguanide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Treatment effect of corneal infection and improvement of visual acuity in patients with Acanthamoeba keratitis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with 0.02% polyhexamethylene biguanide in patients with Acanthamoeba keratitis.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Acanthamoeba keratitis.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kaji |
Organization
Tsukuba Univeristy
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 Univeristy
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 | 12 | Month | 31 | Day |
Other
Other related information
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=R000019739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
