UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to prevent myopia progression by progressive additional soft contact lens compared with monofocal soft contact lens in children
Title of the study (Brief title)	Clinical trial to prevent myopia progression by progressive additional soft contact lens in children
Region	Japan

Condition
Condition	Myopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the preventive effect of myopia progression in test group compared with control group
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Ocular refraction
Key secondary outcomes	Axial length

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	wearing progressive additional soft contact lens
Interventions/Control_2	wearing monofocal soft contact lens
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	6 years-old <=
Age-upper limit	16 years-old >=
Gender	Male and Female
Key inclusion criteria	Refractive error: -0.75D to -3.5D Corrected visual acuity by spherical Spectacle lens: better than (0.7)
Key exclusion criteria	Anisometropia greater than 1.0D Amblyopia Strabismus
Target sample size	20

Research contact person
Name of lead principal investigator	Takashi Fujikado
Organization	Osaka University School of Medicine
Division name	Applied Visual Science
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3941
Email

Public contact
Name of contact person	Takashi Fujikado
Organization	Osaka University School of Medicine
Division name	Applied Visual Science
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3941
Homepage URL
Email

Sponsor
Institute	Osaka University School of Medicine
Institute
Department

Funding Source
Organization	Menicon Corp.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Itami central ophthalmology clinic
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	大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2013 Year 06 Month 01 Day
Date of closure to data entry	2013 Year 08 Month 01 Day
Date trial data considered complete	2013 Year 10 Month 01 Day
Date analysis concluded	2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Elongation of axial length was significantly reduced in eyes worn by low-additional progressive contactlenses compared with monofocal contactlenses 12 months after lens wear. The original point was set after 1month of wearing.
Other related information

Management information
Registered date	2012 Year 05 Month 19 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009401