Low-Dose Atropine for Treatment of Myopia

Phase 3

Completed

Brief Summary: Study Objectives

The objectives for this randomized trial are:

1. 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).

2. 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: Study Objectives

The objectives for this randomized trial are:

1. 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).

2. 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Eyedrops	Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Atropine Group	Atropine	0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops

Primary Outcome Measures

Name	Time	Method
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.	At 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent	At 30 months	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.

Locations (13): Vanderbilt University Medical Center - Vanderbilt Eye Institute
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Nashville, Tennessee, United States
Rocky Mountain Eye Care Associates
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Salt Lake City, Utah, United States
University of Alabama at Birmingham
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Birmingham, Alabama, United States
St Luke's Hospital
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Boise, Idaho, United States
Ticho Eye Associates
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Chicago Ridge, Illinois, United States
The Emory Eye Center Dept of Ophthalmology
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Atlanta, Georgia, United States
Boston Children's Hospital Waltham
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Boston, Massachusetts, United States
Eye Care Associates, Inc.
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Poland, Ohio, United States
Pediatric Ophthalmology Associates, Inc.
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Columbus, Ohio, United States
University of Houston College of Optometry
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Houston, Texas, United States
Casey Eye Institute
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Portland, Oregon, United States
Illinois College of Optometry
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Chicago, Illinois, United States
Dean A. McGee Eye Institute, University of Oklahoma
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Oklahoma City, Oklahoma, United States