Phase 3
N=187
Low-Dose Atropine for Treatment of Myopia
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03334253 ↗Enrolled (actual)
187
Serious AEs
1.1%
Results posted
May 2023
Primary outcome: Primary: Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. — 0; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atropine (Drug); Placebo Eyedrops (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent |
1; 0; 2; 1; 5; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 5 years to 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.
Data sourced from ClinicalTrials.gov (NCT03334253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.