UMIN-CTR Clinical Trial

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 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.
Key secondary 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.

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 Yoshitsugu Middle name Last name Inoue
Organization	Tottori University, Faculty of Medicine
Division name	Division of Ophthalmology and Visual Science
Zip code	683-8504
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 Yoshitsugu Middle name Last name Inoue
Organization	Tottori University, Faculty of Medicine
Division name	Division of Ophthalmology and Visual Science
Zip code	683-8504
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	Institutional Review Board of Tottori University, Faculty of Medicine
Address	36-1, Nishi-cho,Yonago,Tottori 683-8504 Japan
Tel	0859-38-7051
Email	me-rinshoukenkyu@ml.adm.tottori-u.ac.jp

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	Completed
Date of protocol fixation	2017 Year 08 Month 04 Day
Date of IRB	2017 Year 08 Month 25 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2022 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	2022 Year 03 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032658