UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and satety,topical ganciclovir case of cytomegalovirus corneal endotheliitis
Title of the study (Brief title)	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	Yukinobu Okajima
Organization	Toho univesity omori hospital
Division name	ophthalmology
Address	6-11-1omorinishi otaku tokyo
TEL	03-3672-4151
Email	yukinobu.okajima@med.toho-u.ac.jp

Public contact
Name of contact person	Yukinobu Okajima
Organization	Toho univesity omori hospital
Division name	General Affairs Division
Address	6-11-1omorinishi otaku tokyo
TEL	03-3672-4151
Homepage URL
Email	yukinobu.okajima@med.toho-u.ac.jp

Sponsor
Institute	Toho university
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030777