PALO ALTO, Calif., May 2, 2019 /PRNewswire/ -- SightGlass Vision, Inc., a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, today 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 two 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," said Jill Woods, Clinical Research Manager and research optometrist, Centre for Ocular Research & Education (CORE), University of Waterloo, Ontario, Canada.
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.
Myopia has seen a dramatic increase in prevalence over the past several decades. In the early 1970's, only 25 percent of Americans were nearsighted. By the early 2000's, that number had jumped to more than 40 percent. Myopia is the leading cause of irreversible blindness in parts of Asia and it is estimated that almost half of the entire world's population, or five billion people, will be nearsighted by 2050. This increase is thought to relate to lifestyle changes, including less time outdoors and more eye-straining or work-related activities such as reading and screen time. It has been well established that myopia often progresses rapidly during childhood. Myopia progresses into the teen years and early adulthood, leaving many with significantly impaired sight or even serious eye conditions that can cause blindness. This results in the need for stronger prescription glasses and increases the risk of potentially blinding conditions such as glaucoma and retinal detachment in adulthood. Glasses and contact lenses currently available in the U.S. only correct myopia, but do not help prevent it from getting worse. Early intervention is key to preventing high myopia from developing.
About the CYPRESS TrialThe 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.
About SightGlass Vision, Inc.SightGlass Vision, Inc. is a clinical-stage medtech startup company focused on ending nearsightedness (myopia). Headquartered in Palo Alto, CA, SightGlass is developing innovative spectacle lenses to reduce the progression of myopia in children. Based on groundbreaking research from the University of Washington, SightGlass was founded in 2016 by Professors Jay and Maureen Neitz, who are world-renowned vision researchers, and Dr. Thomas Chalberg, a serial entrepreneur in the biotechnology and medical device sectors. For more information, please visit www.sightglassvision.com.
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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 two 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.
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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," said Jill Woods, Clinical Research Manager and research optometrist, Centre for Ocular Research & Education (CORE), University of Waterloo, Ontario, Canada.
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.
Myopia has seen a dramatic increase in prevalence over the past several decades. In the early 1970's, only 25 percent of Americans were nearsighted. By the early 2000's, that number had jumped to more than 40 percent. Myopia is the leading cause of irreversible blindness in parts of Asia and it is estimated that almost half of the entire world's population, or five billion people, will be nearsighted by 2050. This increase is thought to relate to lifestyle changes, including less time outdoors and more eye-straining or work-related activities such as reading and screen time. It has been well established that myopia often progresses rapidly during childhood. Myopia progresses into the teen years and early adulthood, leaving many with significantly impaired sight or even serious eye conditions that can cause blindness. This results in the need for stronger prescription glasses and increases the risk of potentially blinding conditions such as glaucoma and retinal detachment in adulthood. Glasses and contact lenses currently available in the U.S. only correct myopia, but do not help prevent it from getting worse. Early intervention is key to preventing high myopia from developing.
About the CYPRESS TrialThe 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.
About SightGlass Vision, Inc.SightGlass Vision, Inc. is a clinical-stage medtech startup company focused on ending nearsightedness (myopia). Headquartered in Palo Alto, CA, SightGlass is developing innovative spectacle lenses to reduce the progression of myopia in children. Based on groundbreaking research from the University of Washington, SightGlass was founded in 2016 by Professors Jay and Maureen Neitz, who are world-renowned vision researchers, and Dr. Thomas Chalberg, a serial entrepreneur in the biotechnology and medical device sectors. For more information, please visit www.sightglassvision.com.
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SOURCE SightGlass Vision, Inc.
