Low-Dose Atropine for Treatment of Myopia

Completed · Phase 3 · Has a placebo group

Conditions studied: Myopia

In brief

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.

Key facts

Study ID: NCT03334253
Run by: Jaeb Center for Health Research
People needed: 200
Starts: 2018-06-01
Expected to finish: 2022-09-12
Last updated by the study team: 2026-07-31

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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