Clinical trial NCT03334253: Low-Dose Atropine for Treatment of Myopia
Official title: Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Keywords: Myopia
atropine
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Pediatric Eye Disease Investigator Group
name: National Eye Institute (NEI)
First posted: 2017-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
timeFrame: At 24 months
Secondary outcomes:
measure: Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
timeFrame: At 30 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Atlanta
country: United States
facility: The Emory Eye Center Dept of Ophthalmology
state: Georgia
city: Boise
country: United States
facility: St Luke's Hospital
state: Idaho
city: Chicago Ridge
country: United States
facility: Ticho Eye Associates
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital Waltham
state: Massachusetts
city: Columbus
country: United States
facility: Pediatric Ophthalmology Associates, Inc.
state: Ohio
city: Poland
country: United States
facility: Eye Care Associates, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute, University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Vanderbilt Eye Institute
state: Tennessee
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Eye Care Associates
state: Utah
Study officials:
affiliation: Wilmer Eye Institute
name: Michael X Repka, MD, MBA
role: STUDY_CHAIR
affiliation: University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care
name: Katherine K Weise, OD, MBA
role: STUDY_CHAIR
References:
citation: Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855.