UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
Title of the study (Brief title)	The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
Region	Japan

Condition
Condition	Mild or moderate myopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to verify the safety and the ability to control the progression of myopia of 0.01% atropine ophthalmic solution in Japanese children diagnosed with mild or moderate myopia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline in objective spherical equivalent at the end of 24 months of drug treatment.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.01% atropine ophthalmic solution
Interventions/Control_2	Placebo ophthalmic solution
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	12 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Male or female children aged 6 -to 12 years (elementary school grades 1-6) at the time of consent (2) Children with a decrease in visual acuity in the vision assessment in a school physical examination within the past year. (3) Children with a cycloplegic objective spherical equivalent of -1.00D to-6.00D in each eye (4) Children with anisometropia within 1.50D. (5) Children with astigmatism within +/- 1.50D (6) Children with corrected visual acuity of at least 1.0 (7) Children with no intraocular pressure abnormalities (8) Children capable of undergoing cycloplegia (9) Children who can undergo outpatient examinations per protocol (10) Written informed consent to participate in the study obtained from the child personally and from a person with parental authority
Key exclusion criteria	(1) Children with abnormal visual function bilaterally (2) Children with amblyopia or manifest strabismus (3) Children with difference in objective spherical equivalent with and without cycloplegia of more than 1.00D in each eye (4) Children with ocular disorders other than myopia (5) Children with ocular or systemic disorders that potentially affect myopia or refractive power (6) Children who have received previous treatment for myopia that included atropine therapy such as contact lenses, bifocal lenses, or progressive lenses with atropine therapy (however, this does not apply to children who discontinued 0.4% tropicamide ophthalmic solution at least 3 months previously) (7) Children with a history of cardiovascular or respiratory disease (8) Children who have received pharmacotherapy for asthma in the past year (9) Children with a history of allergy to atropine, cyclopentolate, or benzalkonium (10) Children who cannot instill medication into the eye (11) Children who may require contact lenses, bifocal lenses, or progressive lenses during the clinical study period (12) Children deemed otherwise unsuitable for the study by the (sub)investigator
Target sample size	180

Research contact person
Name of lead principal investigator	Shigeru Kinoshita,M.D.,Ph.D.
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Frontier Medical Science and Technology for Ophtalmology
Address	465 Kajiicho, Hirokoji agaru, Kawaramachi-dori Street, Kamigyo-ku Ward, Kyoto City, Kyoto, Japan
TEL	+81-75-251-5578
Email	shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person	Atropine for Childhood Myopia study secretariat
Organization	Satt Co., Ltd.
Division name	Clinical Research Group
Address	5F, ACN Shinjuku Bldg. 2-12-8 Shinjuku, Shinjuku-ku, Tokyo 160-0022,Japan
TEL	+81-3-5312-5026
Homepage URL
Email	atropine@sa-tt.co.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Japanese Research Center of Refractive Surgery
Organization
Division
Category of Funding Organization	Non profit foundation
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	京都府立医科大学病院（京都） 慶應義塾大学病院（東京都） 旭川医科大学病院（北海道） 大阪大学医学部附属病院（大阪府） 川崎医科大学総合医療センター（岡山県） 筑波大学附属病院（茨城県） 日本医科大学付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 07 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 06 Month 23 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020896