UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007127
Receipt number R000008377
Scientific Title Ganciclovir eye drop for the treatment of cytomegalovirus anterior uveitis
Date of disclosure of the study information 2012/03/10
Last modified on 2015/07/24 16:58:28

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Basic information

Public title

Ganciclovir eye drop for the treatment of cytomegalovirus anterior uveitis

Acronym

Ganciclovir eye drop for CMV anterior uveitis

Scientific Title

Ganciclovir eye drop for the treatment of cytomegalovirus anterior uveitis

Scientific Title:Acronym

Ganciclovir eye drop for CMV anterior uveitis

Region

Japan


Condition

Condition

cytomegalovirus anterior uveitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the efficacy and side effects of ganciclovir eye drop for the treatment of cytomegalovirus anterior uveitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity, intraocular pressure, and the degree of anterior segment inflammation

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

Ganciclovir eye drop (0.5%) is applied four times a day in the affected eye.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the patients with cytomegalovirus anterior uveitis who are under hospitalization or going to hospital regularly

Key exclusion criteria

(1) the patients who refsed the consent for this study
(2) the patient judged to be unsuitable for study participation by doctor in charge

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sentaro Kusuhara

Organization

Kobe University Graduate School of Medicine

Division name

Division of Ophthalmology, Department of Surgery

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6048

Email

kusu@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sentaro Kusuhara

Organization

Kobe University Graduate School of Medicine

Division name

Division of Ophthalmology, Department of Surgery

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6048

Homepage URL


Email

kusu@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

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

2012 Year 03 Month 10 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

Completed

Date of protocol fixation

2012 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 01 Month 24 Day

Last modified on

2015 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name