Authors: 
Baskar Arumugam, Paul Chamberlain, David Hammond, Arthur Bradley, Martin Rickert, Jun Jiang, Xiao Yang and Ruihua Wei and.
 

Purpose:
The dual-focus, daily disposable contact lenses (omafilcon A) obtained US FDA and China NMPA approval for slowing the progression of myopia in a Randomised Clinical Trial (RCT). The current presentation reports 6-month and 1-year efficacy data from a multi-centre RCT in China.
 

Methods:
A double-masked clinical trial at three sites in China enrolled children aged 7 to 11 who were randomly assigned to be fit binocularly with either single vision control or dual-focus test lenses (omafilcon A, CooperVision, Inc.). Of 191 enrolled subjects (64 control and 127 test), 175 (55 and 120) completed the 6-month visit and 166 (48 and 118) the 12-month visit. Cycloplegic refractive error and non-contact optical biometry measures of axial length were obtained during study visits. Missing 12-months AL data were imputed using either fixed growth decay model (15% annual decay) or Markov Chain Monte Carlo (MCMC) multiple imputation. Missing 12-months Spherical Equivalent Refractive Error (SERE) data were estimated using AL data and mean relationship between change in AL and SERE (-2.08D/mm). 
 

Results:
Baseline age (8.8±1.5 vs 8.8±1.3) and SERE (-1.91±0.8D vs -2.03±0.8D) were well matched between the control and test groups, respectively (Age: p=0.42 and SERE: p=0.21).  Adjusted mean axial growth with dual-focus test and control single vision lenses were 0.13 mm and 0.23 mm respectively, at 6-months and 0.28 mm and 0.45 mm at 12 months. On average, treatment slowed growth by 0.10 mm and 0.17 mm after 6 months and 12 months of treatment, respectively. Cycloplegic refractive error changes from baseline were also significantly different between the groups at 12-months (control: -0.96D) and test: -0.53D) revealing a 0.43D reduction in myopia progression. 
 

Conclusions:
Dual-focus lens myopia control treatment effects (mm and dioptres) were greater in faster growing eyes of Chinese children than observed previously in a majority non-Asian cohort (Chamberlain et al 2019).
 

Acknowledgements: 
Clinical research organization was Visioncare Research Ltd, UK.
 

Disclosures: 
Employees of CooperVision, Inc. Study sponsored by CooperVision, Inc.