UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026809 |
|---|---|
| Receipt number | R000030777 |
| Scientific Title | Effectiveness and satety,topical ganciclovir case of cytomegalovirus corneal endotheliitis |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/03/31 19:14:03 |
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Basic information
Public title
Effectiveness and satety,topical ganciclovir case of cytomegalovirus corneal endotheliitis
Acronym
Effectiveness and satety,topical ganciclovir case of cytomegalovirus corneal endotheliitis
Scientific Title
Effectiveness and satety,topical ganciclovir case of cytomegalovirus corneal endotheliitis
Scientific Title:Acronym
Effectiveness and satety,topical ganciclovir case of cytomegalovirus corneal endotheliitis
Region
| Japan |
Condition
Condition
cytomegalovirus corneal endotheliitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness and safety of 0.5% ganciclovir cytomegalovirus corneal endothelitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Effectiveness)
1 month,2 months,3 months,6 months after
1) Viral PCR by collecting anterior aqueous humor
2) visual acuity
3) Intra ocular pressure
4) corneal endothelium cells
(safety)
1) hyperemia score
2) corneal epithelial damage
3) stimulation at eye drop
4) itching
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
Administer 0.5% ganciclovir (ganciclovir 1A and saline 100 cc) 6 times a day
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
over 20years old
Diagnosis with cytomegalovirus corneal endothelia
agree with informed consent
Key exclusion criteria
less than 20years old
sitivity for ganciclovir
not agree with informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinobu Okajima |
Organization
Toho univesity omori hospital
Division name
ophthalmology
Zip code
Address
6-11-1omorinishi otaku tokyo
TEL
03-3672-4151
yukinobu.okajima@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukinobu Okajima |
Organization
Toho univesity omori hospital
Division name
General Affairs Division
Zip code
Address
6-11-1omorinishi otaku tokyo
TEL
03-3672-4151
Homepage URL
yukinobu.okajima@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | Month | 31 | 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
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030777
