SightGlass Vision announced topline results from a planned 12-month interim analysis of the company’s pivotal trial evaluating its novel eyeglasses designed to slow the progression of myopia in children. Data from the Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study (CYPRESS, NCT03623074) clinical trial showed that both test arms demonstrated a reduction in myopia progression as assessed by the co-primary outcome measures of axial length and cycloplegic spherical equivalent refraction (SER) change at 12 months.
CYPRESS is a prospective, multicenter, subject- and observer-masked, randomized, controlled pivotal clinical study in 256 children aged 6-to-10 years old across 14 trial sites in the U.S. and Canada. At the time of enrollment, study participants had myopia between -0.75 D and -4.50 D (SER). Trial participants are using one of three types of lenses instead of their normal glasses: control lenses or one of two test lenses. The primary outcome measure is progression of myopia, as defined by change in axial length and change in cycloplegic SER, over 36 months.
“The topline results from the planned 1-year analysis of our pivotal CYPRESS clinical study evaluating our innovative spectacle lenses to reduce the progression of myopia in children showed superiority of both test arms compared to control lenses,” Joe Rappon, OD, MS, FAAO, Chief Medical Officer, said in a company news release. “These findings are highly encouraging. We look forward to additional data from the ongoing trial, and sharing more information about these 12-month data in the near future.”
Data from this trial will be used to support registration and market launch of the company’s novel spectacle lenses. A 24-month interim data analysis is planned for next year. Visit www.clinicaltrials.gov for more information about CYPRESS.