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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035825
Receipt No. R000040808
Scientific Title The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/09

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Basic information
Public title The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Acronym The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Scientific Title The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Fujishima
Organization Tsurumi University Dental Hospital
Division name Department of Ophthalmology
Zip code
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
1st name
Middle name
Last name Asako Kodama
Organization Eiju General Hospital
Division name Department of Ophthalmology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
Two quick tests improved the diagnostic accuracy for conjunctivitis and could diagnose more than 90% of cases.
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
2010 Year 01 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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