UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029966 |
|---|---|
| Receipt number | R000034231 |
| Scientific Title | Exploratory Research on the Markers of Discontinuation of Stromal Herpetic Keratitis Treatment |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2022/03/31 16:55:19 |
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Basic information
Public title
Exploratory Research on the Markers of Discontinuation of Stromal Herpetic Keratitis Treatment
Acronym
Research on the Discontinuation of Stromal Herpetic Keratitis Treatment
Scientific Title
Exploratory Research on the Markers of Discontinuation of Stromal Herpetic Keratitis Treatment
Scientific Title:Acronym
Research on the Discontinuation of Stromal Herpetic Keratitis Treatment
Region
| Japan |
Condition
Condition
Herpetic stromal keratitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the molecule markers to determine the discontinuation of combined therapy by acyclovir ointment and steroid eye drops in herpetic stromal keratitis
Basic objectives2
Others
Basic objectives -Others
To quantify herpes simplex virus (HSV)-DNA by real-time PCR, and various cytokines by ELISA in tear.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To quantify HSV-DNA by real-time PCR, and various cytokines by ELISA in tear consecutively after the discontinuation of acyclovir ointment and steroid eye drops in herpetic stromal keratitis patients under treatment, compare with the subsequent incidence of recurrence, and explore the molecule markers of treatment discontinuation.
Key secondary outcomes
To explore the molecule markers of recurrence prediction by above analyses
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 with unilateral and recurred infiltration(s)
2)Patients with corneal hypoesthesia or past history of definitive dendritic keratitis
3)Patients under combined treatment of acyclovir ointment and steroid eye drops
4)more than 20-year-old (at the timing of informed consent agreement)
1), 2), 3) and 4)
Tear is collected from normal volunteers as control (just once). Inclusion criteria are as follows.
1)No ophthalmological past history other than refractive error
2)No systemic inflammation
3)more than 20-year-old (at the timing of informed consent agreement)
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 HSV
3)Patients with catarrhal corneal infiltration
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.j
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, Faculty of Medicine
Division of Ophthalmology and Visual Science
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
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 | 11 | Month | 14 | 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 | 10 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 15 | 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 HSV-DNA by real-time PCR and various cytokines by ELISA in tear and compare these markers and the subsequent incidence of recurrence.
Management information
Registered date
| 2017 | Year | 11 | Month | 14 | 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=R000034231
| 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 |
