UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035825 |
|---|---|
| Receipt number | 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 12:42:27 |
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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
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
asa-chanyy_4747@kmh.biglobe.ne.jp
Sponsor or person
Institute
Tsurumi University Dental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040808
