SightGlass Vision, Inc., a joint venture of CooperCompanies and EssilorLuxottica, announced the release of 42-month data from the pivotal CYPRESS study extension assessing the safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses for the use of slowing myopia progression in children.
Talk about this technology.
Used in tandem with SightGlass Vision’s patent-protected Diffusion Optics Technology (DOT), the DOT spectacle lenses are designed to reduce contrast signaling within the retina and potentially slow myopia progression—leading to clear central vision with slightly less contrast in the lens’s peripheral component.
Elaborate on this original trial.
The CYPRESS part 1 trial (NCT03623074) was a 3-year, double-masked, randomized, controlled study that enrolled 256 children (ages 6-10; myopia between -0.75 D and -4.50 D) from 14 clinical sites across North America.
Participants were provided spectacles with one of two DOT lens designs (T1 or T2) or standard single-vision control lenses.
Now this extension.
Participants who completed part 1 (n = 42) were invited to enroll in a part 2 trial (NCT04947735), where T1 and control groups continued wearing their initial lenses, while T2 (n = 21) switched to T1 lenses.
A total of 98 participants were re-enrolled from the original 3-year study to generate an additional 6 months of new data.
Of note, axial length (AL) and cycloplegic spherical equivalent refraction (cSER) were measured at the following time points: baseline, 12, 24, 36, and 42 months.
Any limitations or study factors to note?
Given that years 2 and 3 of the study took place during the COVID-19 pandemic, investigators noted that patients’ altered school routines, lifestyle changes, and behavior likely played a role in treatment efficacy of treatment in part 1.
What were the results?
For part 1, 36-month data found that both co-primary endpoints—AL and cSER—were met; a difference in means (T1 minus the control group) for AL was -0.13 (p = 0.018) and 0.33 D for cSER (p = 0.008)
For the extension, LS (least squares) mean change ± SE from 36 to 42 months in AL was 0.08 ± 0.01 mm for T1 and 0.12 ± 0.01 mm for control (p=0.013); in SER, the mean change was -0.12 ± 0.03 D for T1 and -0.21 ± 0.04 D for control (p = 0.051)
There was no statistical difference between the original T1 group and the original T2 group that crossed over to T1 (AL p =0.28, cSER p = 0.85).
In other words...?
The extension study confirmed previous data that the DOT spectacle lenses are effective and have a favorable safety profile in reducing myopia progression in pediatric patients (ages 6 - 10).
Further, the study authors noted that an additional benefit was seen in those patients who wore the lenses for 3 years.
What’s next?
According to Clinical Trials, the CYPRESS study is slated to complete by the end of 2023; the extension study is expected to conclude by June 2025.