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
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
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
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
