Clinical relevance: The control of myopia progression is currently considered an evidence-based therapeutic need.
Background: To determine the efficacy and safety of the Esencia lens, a new soft contact lens (SCL) designed to slow down myopia progression in paediatric patients.
Methods: This study was a randomised, parallel, double-masked clinical trial. Seventy myopic (-0.50 to -8.75 D) boys and girls, 7-15-years of age, were randomised and allocated to one of two groups: (i) study (n = 36) or (ii) control (n = 34). Study group patients were given the Esencia lens, a progressive multifocal and reverse geometry SCL. Control group patients were given conventional SCLs. Efficacy measurements (change in cycloplegic autorefraction and axial length) were measured at baseline and at the six-month intervals over a 12- month period. Visual performance measurements were corneal power, comfort, quality of vision and contact lens fitting. Safety measures included detection of adverse events.
Results: Mean changes in cycloplegic autorefraction after 12-months were -0.28 ± 0.35 D for study and -0.57 ± 0.52 D for control group patients (p = 0.02). A significantly lower increase in axial length was found in the study group (0.13 ± 0.12-mm) compared to control (0.22 ± 0.14-mm) patients (p = 0.03). Compared to control group patients, there was less myopia progression in the study group: 51 and 41 per cent in terms of cycloplegic autorefraction and axial length, respectively. No significant differences between groups for change in corneal power, comfort, vision quality and contact lens fitting were found (p > 0.05). Regarding safety, there were no serious and/or unexpected adverse events during the study.
Conclusions: The Esencia lens seems to be efficacious in slowing down progression of myopia in children compared to traditional SCLs in the short term, with comparable safety features and visual outcomes.
Keywords: clinical trial; contact lens; myopia; myopia control; myopia progression.