UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017319 |
|---|---|
| Receipt number | R000020097 |
| Scientific Title | The use of hospital-prepared ophthalmic solution of 0.1% amphotericin B |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/11/05 21:40:56 |
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Basic information
Public title
The use of hospital-prepared ophthalmic solution of 0.1% amphotericin B
Acronym
The use of hospital-prepared ophthalmic solution of 0.1% amphotericin B
Scientific Title
The use of hospital-prepared ophthalmic solution of 0.1% amphotericin B
Scientific Title:Acronym
The use of hospital-prepared ophthalmic solution of 0.1% amphotericin B
Region
| Japan |
Condition
Condition
fungal keratitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To treat severe cases of fungal keratitis with hospital-prepared ophthalmic solution of amphotericin B and to evaluate the effectiveness and the safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical findings
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
To instill one drop of 0.1% amphotericin ophthalmic solution in patients' eyes from four times per day to every one hour. The period of administration is until the lesion is healed or scarred.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fungal keratitis patients with informed consent
Key exclusion criteria
The patients with a history of side effect by amphotericin B, or the cases that the doctor in charge concluded to be inappropriate for the research.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Akiyama |
Organization
Gunma University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
3-39-15 Showa-machi, Maebashi
TEL
027-220-8338
akiyamah47@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Todokoro |
Organization
Gunma University Hospital
Division name
Ophthalmology
Zip code
Address
3-39-15 Show-machi, Maebashi
TEL
027-220-8338
Homepage URL
dtodokor@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School of Medicine, Department of Ophthalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2019 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020097
