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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028535
Receipt No. R000032658
Scientific Title Exploratory Research of the Use and Its Timing of Steroid Eye Drops in Bacterial Keratitis
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/04

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Basic information
Public title Exploratory Research of the Use and Its Timing of Steroid Eye Drops in Bacterial Keratitis
Acronym Exploratory Research about Steroid Eye Drops in Bacterial Keratitis
Scientific Title Exploratory Research of the Use and Its Timing of Steroid Eye Drops in Bacterial Keratitis
Scientific Title:Acronym Exploratory Research about Steroid Eye Drops in Bacterial Keratitis
Region
Japan

Condition
Condition Bacterial keratitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the markers to determine whether steroid eye drops should be used or not in the treatment of bacterial keratitis, and when they should be used.
Basic objectives2 Others
Basic objectives -Others To quantify bacterial 16s ribosomal DNA and various RNA comprehensively in corneal scrapings, and to quantify various cytokines in tear by ELISA
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To analyze various RNA comprehensively and quantify bacterial 16s ribosomal-DNA in corneal scrapings taken at the first visit and 2 weeks later or before the start of steroid eye drops in definite and presumed cases of bacterial keratitis
Key secondary outcomes To quantify various cytokines by ELISA in tear taken at the first visit and 1, 2, 3, and 4 weeks later in definite and presumed cases of bacterial keratitis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients of suspected bacterial keratitis from clinical findings
2)more than 20-year-old
1)and 2)
Key exclusion criteria 1)Patients difficult to be obtained the agreement of participation of this study
2)Patients with high possibility of other causative agents than bacteria
3)Patients with perforated cornea or extremely thin cornea
1), 2), or 3)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitsugu Inoue
Organization Tottori University, Faculty of Medicine
Division name Division of Ophthalmology and Visual Science
Zip code
Address 36-1, Nishi-cho,Yonago,Tottori 683-8504 Japan
TEL 0859-38-6617
Email yoinoue@grape.med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitsugu Inoue
Organization Tottori University, Faculty of Medicine
Division name Division of Ophthalmology and Visual Science
Zip code
Address 36-1, Nishi-cho,Yonago,Tottori 683-8504 Japan
TEL 0859-38-6617
Homepage URL
Email yoinoue@grape.med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 鳥取大学医学部/Tottori University, Faculty of Medicine

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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
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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To quantify bacterial 16s ribosomal DNA and various RNA comprehensively in corneal scrapings, and various cytokines in tear film by ELISA, and compare these markers and the effect of steroid eye drops.

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2017 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032658

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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