UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043106
Receipt number R000048712
Scientific Title Study of chewing and tear production in healthy young subjects
Date of disclosure of the study information 2021/01/23
Last modified on 2021/02/15 13:00:09

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Basic information

Public title

Relationship between chewing and tear production in healthy young subjects

Acronym

Relationship between chewing and tear production in healthy subjects

Scientific Title

Study of chewing and tear production in healthy young subjects

Scientific Title:Acronym

Study of chewing and tear production in healthy subjects

Region

Japan


Condition

Condition

healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of chewing for tear production in healthy young subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Value of tear production before and after chewing gum

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Gum chewing of two pieces during Schirmer I test with topical anesthesia (once, max 5 minutes).

Interventions/Control_2

No gum chewing during Schirmer I test with topical anesthesia (once, max 5 minutes)

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

30 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Twenty four eyes of 12 healthy subjects between 20 and 29 years old.

Key exclusion criteria

(1) Subjects who do not like the mint taste.
(2) Subjects who inability to chew gum.
(3) Subjects with sufficiently severe dry eye such that refraining from blinking for 5 seconds was impossible.
(4) Subjects had side effects (hyperemia and corneal erosion) caused by oxybuprocaine hydrochloride.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Ken
Middle name
Last name Asakawa

Organization

School of Allied Health Sciences, Kitasato University

Division name

Department of Orthoptics and Visual Science

Zip code

252-0373

Address

1-15-1 Kitasato, Sagamihara, Minami-ku, Kanagawa

TEL

042-778-9667

Email

asaken@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Asakawa

Organization

School of Allied Health Sciences, Kitasato University

Division name

Department of Orthoptics and Visual Science

Zip code

252-0373

Address

1-15-1 Kitasato, Sagamihara, Minami-ku, Kanagawa

TEL

042-778-9667

Homepage URL


Email

asaken@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Kitasato University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

School of Allied Health Sciences, Kitasato University

Address

1-15-1 Kitasato, Sagamihara, Minami-ku, Kanagawa

Tel

042-778-9602

Email

a-soumu@kitasato-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

2021 Year 01 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

16

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

2020 Year 10 Month 27 Day

Date of IRB

2021 Year 01 Month 22 Day

Anticipated trial start date

2021 Year 01 Month 23 Day

Last follow-up date

2021 Year 03 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 23 Day

Last modified on

2021 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048712


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name