Visioneerings PROTECT Clinical Trial: 1-Year Update

Visioneering Technologies, Inc. (ASX: VTI) has released additional information regarding the interim 1-year outcomes from its PROTECT Clinical Trial, which assesses the safety and effectiveness of the NaturalVue Multifocal 1 Day Contact Lenses in managing myopia progression in children. This Phase IV clinical trial adheres to Good Clinical Practice and enrolls myopic children aged 7 to under 13 with specific refractive criteria. The study involved children wearing either NaturalVue Sphere single vision contact lenses (Control Group) or NaturalVue Multifocal soft contact lenses (Test Group) for two years, with the Control Group transitioning to Multifocal lenses at 24 months.

The trial spanned multiple countries and has a 3-year duration, with interim analyses conducted at 1-year and 2-year intervals. Preliminary results at 1 year revealed a significant difference in the primary efficacy endpoint, with the Test Group showing a 58% improvement in refractive error compared to the Control Group. Secondary endpoints, like axial length changes, also favored the Test Group by 56%. No serious device-related adverse events were reported, and both lenses were deemed safe for children as young as seven. The data analysis for statistical significance will be conducted and presented in January 2024 when all first-year visits are complete.

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