MultifocAL COntact Lenses for Myopia (MALCOLM) control in Australian children: a study protocol for a double-blind, contralateral eye, non-inferiority, randomised controlled clinical trial

Abstract

Introduction Myopia is the most common refractive error worldwide, but each dioptre increase in myopia leads to an increased risk of degenerative eye disease and permanent vision impairment. Soft contact lens (CL) designs have been developed to slow myopia and potentially reduce long-term risk, but there is still a need for additional designs of varied materials and parameters to cater for diverse patient needs. The MultifocAL COntact Lenses for Myopia control study aims to compare the efficacy of the Acuvue Oasys for Presbyopia (AOP) CL against the Food and Drug Administration approved MiSight 1-Day multifocal CL in controlling progressive myopia in children using a non-inferiority contralateral eye design.Methods and analysis A double-blind, contralateral eye, non-inferiority, randomised, controlled clinical trial will be conducted at University of New South Wales Sydney, Australia (UNSW). Children (6 to 12 years of age, inclusive) will be randomised to wear AOP in their right or left eye, with the MiSight 1-Day CL fitted to the contralateral eye. The primary outcome is the difference in axial length and cycloplegic objective refraction change between the two CLs over 12 months. Additional outcomes include quality of life, pupillometry and adherence to treatment. To achieve a statistical power of 80% to demonstrate non-inferiority of the AOP to the MiSight 1-Day and taking into consideration a 20% discontinuation rate, the calculated sample size is 72. This trial started recruitment during the recent COVID-19 pandemic in January 2021.Ethics and dissemination Ethics approval has been obtained from the UNSW Human Research Ethics Committee (HC200052), and the study complies with the Declaration of Helsinki and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines. The results of this trial will be disseminated in peer-reviewed publications and conference presentations.Trial registration number ACTRN12620000159954, CTN-00 282–1 v2, NCT06887920.