UMIN-CTR Clinical Trial

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)
Email	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
Email	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
Email

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
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

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