UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016905 |
|---|---|
| Receipt number | R000019504 |
| Scientific Title | Safety study of wiping lid margins with a lid margin brush |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2019/02/12 17:48:18 |
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Basic information
Public title
Safety study of wiping lid margins with a lid margin brush
Acronym
Safety study of wiping lid margins with a lid margin brush
Scientific Title
Safety study of wiping lid margins with a lid margin brush
Scientific Title:Acronym
Safety study of wiping lid margins with a lid margin brush
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform a safety study of using a lid margin brush to wipe lid margins
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptom, tear breakup time, fluorescein staining score, meibum, lid margin findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The safety is verified with respect to subjects at the Ophthalmology Department, by performing improvement estimations before and after wiping lid margins using the brush, and observations on dynamics during the wiping. Evaluation timings are taken before starting (before and after the treatment at the Department of Ophthalmology for subjects) and one month later (each subject is asked to do the wiping every morning at home for evaluation). The evaluations are conducted similarly for each timing. Tap-water, a lid brush and eye shampoo (MediProduct) are used for the wiping.
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
Subjects who agree with the ophthalmological examinations
Key exclusion criteria
1. Subjects with a disorder of the anterior eye part or the outer ocular area, or with a serious disorder in the posterior segment
2. Subjects who underwent any ophthalmological surgical treatment within one month
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Tanabe |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL
03-3353-1211(+81-3-3353-1211)
tennsyoudragon@icloud.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Tanabe |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL
03-3353-1211(+81-3-3353-1211)
Homepage URL
tennsyoudragon@icloud.com
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcophthalmol.biomedcentral.com/track/pdf/10.1186/s12886-019-1052-y
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
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019504
