Low-Dose Atropine for Treatment of Myopia

Study Overview
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Brief Summary
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Study Objectives The objectives for this randomized trial are: To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Detailed Description
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Study Objectives The objectives for this randomized trial are: To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment). To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Official Title
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Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)

Conditions
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Myopia

Intervention / Treatment
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* Drug: Atropine
* Other: Placebo Eyedrops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible. Refractive error meeting the following by cycloplegic autorefraction: Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes Astigmatism <=1.50D in both eyes Anisometropia <1.00D SE Gestational age ≥ 32 weeks. Birth weight >1500g. Parent understands the protocol and is willing to accept randomization to atropine or placebo. Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops. Able to return in 2 to 4 weeks for possible randomization. Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff. Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated. Exclusion Criteria: Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent. Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses. Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression. Known atropine allergy. Abnormality of the cornea, lens, central retina, iris or ciliary body. Current or prior history of manifest strabismus, amblyopia, or nystagmus. Prior eyelid, strabismus, intraocular, or refractive surgery. Down syndrome or cerebral palsy. Females who are pregnant, lactating, or intending to become pregnant within the next 30 months. A negative urine pregnancy test will be required for all females who have experienced menarche.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine Group<br>0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops | Drug: Atropine<br>* Daily 0.01% atropine eyedrops<br>* Other names: Low-Dose Atropine;|
| Placebo Comparator: Placebo Group<br>Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops | Other: Placebo Eyedrops<br>* Daily placebo eyedrops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | At 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent | Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months. | At 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, atropine