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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016905 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Normal subjects | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Ophthalmology, Keio University School of Medicine |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019504 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |