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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018041
Receipt No. R000020896
Scientific Title The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
Date of disclosure of the study information 2015/06/23
Last modified on 2018/12/26

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Basic information
Public title The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
Acronym The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
Scientific Title The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Shigeru Kinoshita,M.D.,Ph.D.
Organization Kyoto Prefectural University of Medicine
Division name Department of Frontier Medical Science and Technology for Ophtalmology
Zip code
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
1st name
Middle name
Last name Atropine for Childhood Myopia study secretariat
Organization Satt Co., Ltd.
Division name Clinical Research Group
Zip code
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)

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 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

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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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