Abstract
Purpose :
The Myopia Outcome Study of Atropine in Children (MOSAIC, ISRCTN: 36732601, EudraCT database 2016-003340-37) is an investigator-led, double-masked, placebo-controlled, randomized clinical trial investigating the efficacy, safety and mechanisms of action of 0.01% atropine eye drops for managing myopia progression in a predominantly white, European population.
Methods :
250 subjects (207 White ethnicity, 43 non-White ethnicity) aged 6-16 years myopes were randomly allocated (2:1 randomization, 167 treatment, 83 placebo) to nightly atropine 0.01% or placebo eye drops in both eyes for 24 months.The atropine was an unpreserved single-dose preparation, independently validated for stability and drug concentration. The primary outcome measure was cycloplegic spherical equivalent refractive error (SER) change at 24 months. Secondary outcome measures included axial length change and safety and acceptability profile of 0.01% atropine. Statistical analysis was conducted using linear mixed models with random intercepts to account for correlated data.
Results :
No significant differences were present in the baseline characteristics of the treatment and control groups. 204 participants (81.6%) completed the 24-month study [136 (81.4%) treatment, 68 (81.9%) control]. No significant adverse effects were noted and there was no significant difference in drop out between treatment and control groups. The degree of change in SER was not significantly different between atropine 0.01% and placebo groups at 24 months (treatment effect=0.10D, p=0.08), but axial length change was significantly lower in the atropine 0.01% group, compared to the placebo group (-0.08mm, p=0.006). At 24 months, significant differences in SER (0.14D, P = 0.049) and axial length (-0.11mm, P = 0.002) were observed in participants of White ethnicity but not in non-White children (SER 0.05D, P = 0.89; AXL.0.008mm, P = 0.93).
Conclusions :
Atropine 0.01% was well tolerated in this European population. The study failed to meet its primary endpoint of SER change at 2 years. However, significant treatment effects were noted for axial length at 2 years and for SER and axial length among participants of White ethnicity. The study was impacted by COVID-19 public health restrictions, which may have adversely affected the overall study outcomes.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.