UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028535 |
|---|---|
| Receipt number | 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 | 2022/03/31 16:54:38 |
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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 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
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
yoinoue@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
