UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Title of the study (Brief title)	The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Region	Japan

Condition
Condition	keratitis, conjunctivitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the improvement of the diagnostic accuracy for conjunctivitis by using two quick tests.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detection rate with two quick tests for conjunctivitis
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	We perform two quick tests once on the same visit.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	eyes with relatively severe conjunctivitis
Key exclusion criteria	conjunctivitis with Stevens-Johnson syndrome and/or proliferative atopic keratoconjunctivitis contact lens wearers eyes with pretreatment
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Fujishima
Organization	Tsurumi University Dental Hospital
Division name	Department of Ophthalmology
Address	2-1-3 Tsurumi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8501 Japan
TEL	81455808500
Email	fujishima117@gmail.com

Public contact
Name of contact person	Asako Kodama
Organization	Eiju General Hospital
Division name	Department of Ophthalmology
Address	2-23-16 Higashiueno, Taito-ku, Tokyo 110-8645 Japan
TEL	81338338381
Homepage URL
Email	asa-chanyy_4747@kmh.biglobe.ne.jp

Sponsor
Institute	Tsurumi University Dental Hospital
Institute
Department

Funding Source
Organization	We have no funding and conflicts of interest.
Organization
Division
Category of Funding Organization	Self funding
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	2019 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 05 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2010 Year 09 Month 30 Day
Date of closure to data entry	2010 Year 11 Month 30 Day
Date trial data considered complete	2010 Year 11 Month 30 Day
Date analysis concluded	2011 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Two quick tests improved the diagnostic accuracy for conjunctivitis and could diagnose more than 90% of cases.
Other related information

Management information
Registered date	2019 Year 02 Month 09 Day
Last modified on	2019 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040808