Myopic Eyes in Children Responded Better to Atropine 0.01% than to Atropine 0.02%

After 3 years of treatment, more myopic eyes of children aged 6–10 years responded to atropine 0.01% eye drops than to either atropine 0.02% eye drops or placebo.

Study Design

The phase 3 randomized, placebo-controlled, double-masked Childhood Atropine for Myopia Progression (CHAMP) clinical trial, conducted in North America and Europe, compared the efficacy and safety of atropine 0.01% vs atropine 0.02% vs placebo for myopia progression. Children were included if they had low-to-moderate myopia (−0.50 D to −6.00 D) and were aged 3–17 years, but the authors stopped enrolling patients aged ≥11 years after the first 66 patients. In total, 573 study participants were included in the safety population and 489 participants, all aged 6–10 years, were included in the modified intention-to-treat (mITT) efficacy population. The primary endpoint was the number of eyes that showed <0.50 D of myopia progression (treatment response) with atropine 0.02% eye drops at 36 months, and the secondary outcomes were progression with atropine 0.01% eye drop treatment and changes in spherical equivalent (SE) and axial length (AL) elongation at 36 months.

Outcomes

At 36 months, the proportion of responder eyes was similar for all 3 treatment groups. The response rate with atropine 0.01% was significantly better than placebo at all timepoints; for atropine 0.02% vs placebo, the response rate was significantly better only at the 12-month timepoint. Mean myopic SE progression was −1.04 D for atropine 0.01% and −1.28 D for placebo, a significant difference; similar findings were seen for mean change in AL elongation. Both the 0.01% and 0.02% concentrations of atropine were safe and well tolerated.

Limitations

The unequal numbers of participants in each of the 3 cohorts, the overrepresentation of children aged 6–10 years, and the limited participation of children aged 11–17 years make the results challenging to interpret.

Clinical Significance

Findings from the mITT study population noted a better response rate with atropine 0.01% than atropine 0.02% or placebo in children with low or moderate myopia. However, health care professionals who treat this population will need to take into consideration the inconsistent results of various studies of low-dose atropine for myopia control published over the last 12 months, especially when having conversations with parents/caregivers. While safety concerns have not been noted with the atropine 0.01% and 0.02% concentrations, their long-term effectiveness is uncertain. It is recommended that future pharmacologic studies include participants older than 10 years.

Financial Disclosures: Dr. Jennifer Galvin discloses no financial relationships.