UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032132 |
|---|---|
| Receipt number | R000036246 |
| Scientific Title | Microbiome analysis of ocular surface diseases |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2022/11/04 09:28:03 |
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Basic information
Public title
Microbiome analysis of ocular surface diseases
Acronym
Microbiome analysis of ocular surface diseases
Scientific Title
Microbiome analysis of ocular surface diseases
Scientific Title:Acronym
Microbiome analysis of ocular surface diseases
Region
| Japan |
Condition
Condition
Ocular surface diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation of microbiome and severity of diseases or treatment, we will examine the microbiome of the ocular surface in patients with ocular surface diseases or contact lens wearer.
Basic objectives2
Others
Basic objectives -Others
microbiome
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
microbiome
Key secondary outcomes
severity of diseases
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Swab ocular surface bacteria with sterile cotton swab.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with ocular surface diseases
(a) allergic conjunctival diseases, infectious and non-infectious keratoconjunctivitis, blepharitis including Meibomian gland dysfunction, dry eye or contact lens wearer
(b) Subjects obtained written informed consent
(2) Healthy subjects with written informed consent
Key exclusion criteria
Subjects those are judged as inappropriate by doctors.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Fukuda |
Organization
Kochi University
Division name
Kochi Medical School, Department of Ophthalmology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-city, Kochi 783-8505, Japan
TEL
088-880-2391
k.fukuda@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | XX |
| Middle name | |
| Last name | Tsuzuki |
Organization
Kochi University
Division name
General Affairs and Planning Section Office for the Promotion of Research, Kochi Medical School
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-city, Kochi 783-8505, Japan
TEL
088-880-2180
Homepage URL
rinri21@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University, Kochi Medical School, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ishizuchi Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dept. of Ophthalmology, Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku-city, Kochi
Tel
0888802391
k.fukuda@kochi-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036246
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
