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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007127
Receipt No. 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

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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
Institute Kobe University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.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


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