UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012498 |
|---|---|
| Receipt number | R000014632 |
| Scientific Title | Topical application of ambisome in the treatment of keratomycosis. |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2020/12/10 21:30:16 |
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Basic information
Public title
Topical application of ambisome in the treatment of keratomycosis.
Acronym
Topical application of ambisome in the treatment of keratomycosis.
Scientific Title
Topical application of ambisome in the treatment of keratomycosis.
Scientific Title:Acronym
Topical application of ambisome in the treatment of keratomycosis.
Region
| Japan |
Condition
Condition
Keratomycosis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effect of topical ambisome in the patients with keratomycosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
vision, ocular pressure, slit-lamp examination
Key secondary outcomes
Ocular fundus
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
Topical application of ambisome
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with keratomycosis.
Key exclusion criteria
Patients with allergic reaction to polyene antifungal reagents.
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
Opthalmology
Zip code
3050006
Address
1-1-1 Tennnoudai Tsukuba Ibaraki Japan
TEL
0298533148
kajiyuichi@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kaji |
Organization
Tsukuba University
Division name
Opthalmology
Zip code
3050006
Address
1-1-1 Tennnoudai Tsukuba Ibaraki Japan
TEL
0298533148
Homepage URL
http://www.md.tsukuba.ac.jp/clinical-med/ophthalmology/
kajiyuichi@gmail.com
Sponsor or person
Institute
Tsukuba University
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University
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
| 2014 | Year | 01 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 05 | 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=R000014632
| 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 |
