UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dual-focus soft contact lens wear on myopia progression
Title of the study (Brief title)	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	Funaki Toshinari
Organization	Juntendo University School of Medicine
Division name	Department of Ophthalmology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5802-1093
Email	funa5150@juntendo.ac.jp

Public contact
Name of contact person	Funaki Toshinari
Organization	Juntendo University School of Medicine
Division name	Department of Ophthalmology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5802-1093
Homepage URL
Email	funa5150@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019799