Low-Dose Atropine for Treatment of Myopia

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.

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.