Randomized Trial of Soft Contact Lenses with Novel Ring Focus for Controlling Myopia Progression

PURPOSE: To evaluate efficacy and vision with 2 prototype myopia control soft contact lenses with noncoaxial ring-focus designs (for enhancing efficacy [EE] and enhancing vision [EV]) compared with dual-focus (DF) and single-vision (SV) designs. DESIGN: Multicenter, 6-month, randomized, controlled, double-masked clinical trial. PARTICIPANTS: One hundred ninety-nine myopic (−0.75 diopters [D] to −4.50 D) children aged 7 to 12 years. METHODS: Participants were randomized with stratification into myopia control (EE, EV, or DF) or SV arms at 9 clinical sites in 3 countries. Postcycloplegia axial length (AL) and spherical equivalent autorefraction (SECAR) were measured at baseline and 26 weeks. Axial length was also measured without cycloplegia at baseline, 1, 4, 13, and 26 weeks. Progression was analyzed using linear mixed models by intention-to-treat population. Visual acuity (VA) and vision quality were monitored. MAIN OUTCOME MEASURES: Axial elongation, change in SECAR. RESULTS: A total of 185 subjects completed the study (n = 44, 49, 45, and 47 for EE, EV, DF, and SV, respectively). There were no serious/significant ocular adverse events. After 26 weeks, EE, EV, and DF all had statistically significantly less axial elongation than SV (unadjusted mean [standard deviation]: EE, 0.079 [0.125]; EV, 0.119 [0.101]; DF, 0.135 [0.117]; SV; 0.189 [0.121] mm). The estimated least-square mean (LSM) differences (adjusted 95% confidence interval) compared with SV were −0.105 (−0.149, −0.062), −0.063 (−0.106, −0.020), and −0.056 (−0.100, −0.013) mm for EE, EV, and DF, respectively. Enhancing efficacy alone had statistically significantly less progression of SECAR than SV (EE: −0.12 [0.27] D vs. SV: −0.35 [0.33] D; LSM difference: 0.22 D [0.09, 0.35]). Enhancing efficacy also had statistically significantly less axial elongation than DF (−0.049 mm [−0.093, −0.004]). Changes in AL and SECAR of EV and DF were not statistically different. All 3 myopia control lenses had mean VA close to 0.00 logarithm of the minimum angle of resolution (logMAR) with estimated 95% upper confidence limits <0.10 logMAR. Enhancing efficacy and DF produced similar reports of halos but more than EV and SV. CONCLUSIONS: The prototype contact lenses met the design intent; EE was more efficacious in slowing axial elongation than DF with comparable vision performance, whereas EV produced comparable efficacy to DF with similar vision performance to SV.