SightGlass Vision Presents Clinical Trial Data From Novel Lenses to Control Myopia
SightGlass Vision announced that data assessing the tolerability of three iterations of its novel lenses designed to control nearsightedness in children were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting, held April 28 to May 2, 2019 in Vancouver, British Columbia.
Data presented at ARVO 2019 were from WALNUT, the company’s prospective, randomized, subject-masked, three-arm clinical study of 21 healthy myopic (-1.00 to -4.00 DS) children aged six-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 showed that all three lens designs were well tolerated. In addition, high-contrast distance visual acuity in both high and low room illumination were at high levels, not different to refraction acuity levels (P>0.05). There were 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. By some measures, study participants preferred their habitual spectacles to lens design 3. Of note, all three lens designs showed a trend toward reduction in axial length over the two 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.
“These data clearly demonstrate all three lens designs provided similarly high levels of distance and near visual acuity, and contrast sensitivity. The axial length reductions noted were encouraging and I am very excited to see the results of the longer-term study,” Jill Woods, Clinical Research Manager and research optometrist, Centre for Ocular Research & Education (CORE), University of Waterloo, Ontario, Canada, said in a company news release.
Joe Rappon, OD, MS, FAAO, Chief Medical Officer at SightGlass Vision, added, “We are encouraged by the results from the WALNUT clinical study, and believe that our novel spectacle design has the potential to reduce myopia progression in children. Results from WALNUT were used to determine the two spectacle lens designs currently being tested in CYPRESS, our pivotal trial evaluating the safety and efficacy of our novel lenses compared to standard spectacles to reduce the rate of progression of myopia in children aged six-to-10 years old. We are delighted that CYPRESS completed enrollment earlier this year and look forward to the planned, one-year interim analysis.”
SightGlass expects to report initial results from the CYPRESS study in 2020, followed by additional data with longer-term follow up.
The CYPRESS trial is a multicenter, double-blinded, randomized, controlled clinical trial that enrolled 265 patients aged six-to-10 years old across 14 clinical sites in the U.S. and Canada. The primary outcome measure is progression of myopia (change in axial length and change in spherical equivalent refraction) over 36 months. Trial participants are using one of three types of lenses instead of their normal glasses. The eyeglasses used in the study are provided at no cost. Study participants are being financially compensated for time and travel expenses, and are receiving comprehensive eye care at no cost during the study duration.