UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Acronym	Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Scientific Title	Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Scientific Title:Acronym	Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Region	Japan

Condition
Condition	high- or moderate-grade myopia
Classification by specialty	Ophthalmology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the efficacy of 0.01% atropine ophthalmic solution on myopia progression and axial elongation of the eye in the school children diagnosed with high- or moderate-grade myopia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in objectively-measured spherical equivalent refraction and axial length of the eye during the follow-up period of 12 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	daily application of 0.01% atropine ophthalmic solution to the both eyes for 12 months
Interventions/Control_2	spectacle correction only
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) Children aged 6 to 12 years at the time of consent (2) Children with spherical equivalent refraction of -4.50 to-9.00 D in each eye (3) Children with anisometropia within 1.50 D. (4) Children with astigmatism within +/-1.50 D (5) Children with corrected visual acuity of at least 1.0 (6) Children with intraocular pressure equal to or lower than 21mmHg (7) Children capable of undergoing cycloplegia (8) Children who can undergo outpatient examinations per protocol (9) Written informed consent to participate in the study obtained from the child personally and a person with parental authority
Key exclusion criteria	(1) Children with abnormal binocular function (2) Children with amblyopia or manifest strabismus (3) Children with ocular disorders other than myopia (4) Children with ocular or systemic disorders that potentially affect myopia or refractive power (5) Children who have received previous treatment for myopia control that included atropine therapy, bifocal lenses, progressive lenses, and Ortho-K. (6) Children with a history of cardiovascular or respiratory disease (7) Children who have received pharmacotherapy for asthma in the past year (8) Children with allergy to atropine, cyclopentolate, or benzalkonium (9) Children who cannot use eye drops (10) Children who plans to use contact lenses during the follow-up period
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Satoshi Middle name Last name Hasebe
Organization	Kawasaki Medical School
Division name	Department of Ophthalmology 2
Zip code	700-8505
Address	2-6-1 Nakasange, Kita-ku, Okayama
TEL	086-225-2111
Email	shasebe2009@yahoo.co.jp

Public contact
1st name of contact person	1st name Hasebe Middle name Last name Satoshi
Organization	Kawasaki Medical School
Division name	Department of Ophthalmology 2
Zip code	700-8558
Address	2-6-1 Nakasange, Kita-ku, Okayama
TEL	086-225-2111
Homepage URL	https://g.kawasaki-m.ac.jp/dept/ganka/ekigaku
Email	shasebe2009@yahoo.co.jp

Sponsor
Institute	Kawasaki Medical School Department of Ophthalmology 2
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology, and Kawasaki Medical School
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	086-235-6938
Email	mae6605@adm.okayama-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	川崎医科大学総合医療センター（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 15 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	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 10 Month 16 Day
Anticipated trial start date	2018 Year 03 Month 15 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 06 Month 15 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 06 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032676