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)

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 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


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

Value
https://center6.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