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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name