UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019237
Receipt number R000019799
Scientific Title Effect of dual-focus soft contact lens wear on myopia progression
Date of disclosure of the study information 2015/10/05
Last modified on 2017/09/08 20:23:42

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Basic information

Public title

Effect of dual-focus soft contact lens wear on myopia progression

Acronym

Effect of soft contact lens wear on myopia progression

Scientific Title

Effect of dual-focus soft contact lens wear on myopia progression

Scientific Title:Acronym

Effect of soft contact lens wear on myopia progression

Region

Japan


Condition

Condition

myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Singel vision spectacle and center-distance bifocal contact lens are done a comparison wearing and examined the myopia progress suppression effect by the center-distance bifocal contact lens.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The difference of subjective refractivity, objective refractivity and optic axis length between two groups after 1 year from wearing

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Spectacles group
One year

Interventions/Control_2

Bifocal contact lenses group
One year
Replacement on a daily basis
Over 8 hour wearing per day

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

10 years-old <=

Age-upper limit

14 years-old >=

Gender

Male and Female

Key inclusion criteria

No experience of contact lens wear
-1.0D to -6.0D refraction in each eyes under the non-accommodative palsy
Total astigmatism diopter within -1.5D in each eyes
Corrected visual acuity over 1.0 in each eyes
No misalignment of the eyes
No history of premature infant
No maldevelopment of the eyes and systemic
No use of drug
Be able to wear 1 week in contact lenses group (More than once a practice for wearing)
Be able to obtain the voluntary consent document by patient and the agreemnt of legally acceptable representative

Key exclusion criteria

If principal investigator and investigator has determined unsuitable

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Funaki Toshinari

Organization

Juntendo University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1093

Email

funa5150@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Funaki Toshinari

Organization

Juntendo University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1093

Homepage URL


Email

funa5150@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

SEED co., ltd.

Organization

Division

Category of Funding Organization

Profit organization

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 10 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

Preinitiation

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 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 10 Month 05 Day

Last modified on

2017 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019799


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name