The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)

JRCT ID: jRCTs051180041

Registered date:30/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild or moderate myopia
• Date of first enrollment: 05/08/2015
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Individual subjects are randomly assigned to the study drug group and the placebo group, and the assignment drug is instilled once a day before going to bed. Observe and examine after medication 2 weeks as the baseline, 6 months after dosing, 12 months, 18 months, 24 months after medication. Also, after completion of dosing, set a rest period of one month and observe termination of the test at the end of the withdrawal period.

Outcome(s)

• Primary Outcome: Change from baseline in objective spherical equivalent at the end of 24 months of drug treatment.

Secondary Outcome

(1) Amount of change in ocular axial length from the time of baseline observation to the time of observation completion observation for 24 months
(2) Objective Equivalent Spherical Frequency and Change in Eye Shaft Length at the Start of Test (Registration) to 24 Month Period of Observing Completion of Dosing
(3) Change in objective equivalent spherical power and change in eye axis length at each observation time from the time of baseline observation to the time of observation end observation (when the test is stopped)
(4) Change in objective equivalent spherical power and change in eye axis length at each observation time from the start of the test (registration time) to the end of examination observation (when the test is stopped when the test is stopped)
(5) Presence or absence of influence on eyeball and external eye part, accommodation function, intraocular pressure, fundus and pupil diameter from the start of the test (registration time) to the end of examination observation (when stopping the examination)
(6) Incidence rate of adverse events and side effects from the start of the test (registration time) to the end of the study (when the test is stopped when the test is stopped)
(7)Evaluate the presence of rebound at 36 months

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 12age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kinoshita Shigeru
• Source(s) of Monetary Support: Japanese Research Center of Refractive Surgery
• Secondary ID(s): UMIN000018041