UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the evaluation of adenovirus antigen detection kit
Title of the study (Brief title)	Evaluation of adenovirus detection kit
Region	Japan

Condition
Condition	epidemic keratoconjunctivitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacy and safety of a novel adenovirus antigen detection kit on epidemic keratoconjunctivitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing the sensitivity and specificity of novel and current kits on adenovirus PCR positivity
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Viral sampling by conjunctival scrapings
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	1 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Cases with acute conjunctivitis diagnosed clinically as epidemic keratoconjunctivitis
Key exclusion criteria	Cases who reject to join this clinical research
Target sample size	50

Research contact person
Name of lead principal investigator	Eiichi Uchio
Organization	Fukuoka University School of Medicine
Division name	Department of Ophthalmology
Address	7-45-1 Nanakuma, Jonan, Fukuoka, Japan
TEL	0928011011
Email	euchio@fukuoka-u.ac.jp

Public contact
Name of contact person	Eiko Matsuda
Organization	Wako Pure Chemical Industries, Ltd.
Division name	Division of Clinical Test Development
Address	3-1-2 Doshomachi, Chuo, Osaka
TEL	0662032392
Homepage URL
Email	matsuda.eiko@wako-chem.co.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Wako Pure Chemical Industries. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	福岡大学病院（福岡県），小沢眼科医院（福岡県），こにし眼科医院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 12 Day
Anticipated trial start date	2017 Year 07 Month 26 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 06 Month 27 Day
Last modified on	2017 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032021