SightGlass Vision to Present Pivotal Clinical Trial Baseline Data Evaluating Novel Lenses to Control Nearsightedness in Children
SightGlass Vision announced that baseline data from CYPRESS, the company’s pivotal trial assessing the safety and efficacy of novel lenses designed to control nearsightedness in children, will be presented at the 17th International Myopia Conference 2019, held September 12-15, 2019 in Tokyo, Japan (“Spectacles and Ortho K” poster session on Saturday, September 14, 2019).
CYPRESS (NCT03623074) is a multicenter, double-masked, randomized controlled pivotal clinical study taking place at 14 sites in the United States and Canada. Two hundred fifty-six subjects met enrollment criteria and were dispensed either control lenses or one of two novel lens designs. Study participants had an average age of 8.7 years (SD ± 1.2 years) (including fractional component of age) and average refractive error of -2.01 D (SD ± 0.9 D) at baseline. Randomization was stratified by age and refractive error. Study participants will be followed for a total of three years. The primary objective of CYPRESS is to compare axial length and spherical equivalent refraction change from baseline after using spectacles containing the novel lens designs to control lenses. Data from the 12-month analysis of CYPRESS will be available in Q2 2020.
“Myopia is increasing dramatically, and millions are at risk of vision-threatening complications due to high myopia. New therapies that are safe and effective in preventing myopia progression are urgently needed, particularly in young children,” Jay Neitz, PhD, Professor and Research Director, Department of Ophthalmology, and Co-director, Neitz Lab, University of Washington, said in a company news release. “We are extremely pleased CYPRESS has been fully enrolled, with demographics representative of the target population. We look forward to the results of the planned interim analysis next year.”
Data will also be presented from the WALNUT study, the company’s prospective, randomized, subject-masked, three-arm clinical study of 21 healthy myopic (-1.00 to ‑4.00 DS) children aged 6-to-12 years old who were habitual spectacle wearers. Study participants were randomized to one of three lens designs for 2 weeks. Lenses were designed to modulate contrast in the periphery of the visual field at three different levels. The primary outcome variables were distance visual acuity, contrast sensitivity, and subjective responses of acceptability assessed using a questionnaire. Other outcome variables included a parent questionnaire, near visual acuity, and axial length measurements.
Results from WALNUT showed that all three lens designs were well tolerated and found no differences between any of the lens designs for high-contrast, high-illumination distance and near acuity, high-contrast, low-illumination distance acuity or contrast sensitivity. Results from the subject questionnaire indicated that the study participants’ experience with lens designs 1 and 2 were similar to each other and to their habitual spectacles. Of note, all three lens designs showed a trend toward reduction in axial length over the 2 weeks of lens wear, with lens design 1 reaching statistical significance in both eyes (P<0.05). The axial length reductions noted in WALNUT are consistent with a therapeutic effect of slowing myopia progression.
Joe Rappon, OD, MS, FAAO, Chief Medical Officer at SightGlass Vision, added, “Results from the WALNUT study were used to select the spectacle lens designs tested in CYPRESS, which completed enrollment in March 2019. We look forward to reporting the planned, one-year interim analysis from CYPRESS in Q2 2020, followed by additional data with longer-term follow up.”