Dopavision has successfully completed enrollment for its MyopiaX-1 trial (NCT04967287), a randomized, active-controlled trial assessing the safety, tolerability, and clinical outcomes of MyopiaX® in pediatric myopia patients.
Initial clinical results are expected in early 2024, with the 12-month trial slated for completion in September 2024. The trial involves 10 clinical sites across Germany, the Netherlands, Portugal, Spain, and the United Kingdom.
This MyopiaX-1 trial is a crucial proof-of-concept study, representing the first clinical evidence for MyopiaX®. Over 100 children aged 6 to 14 with progressive myopia and refractive errors ranging from -0.75 to -5.00 diopters were randomized.
Participants were assigned in a 2:1 ratio to receive MyopiaX® or myopia control spectacles for the initial 6 months, followed by the addition of myopia control spectacles for the MyopiaX® group during the latter half of the study. An independent Data Safety Monitoring Board monitors the trial's clinical safety outcomes on a quarterly basis. Dopavision is developing MyopiaX® as an active medical device.
“Pediatric myopia is a global public health problem that presents a significant burden for children, with an increased risk of long-term eye health complications and impaired quality of life. We designed our treatment approach to control myopia progression as a non-invasive, non-pharmaceutical method,” said Mark Wuttke, CEO of Dopavision.
“Developed as a smartphone application, MyopiaX® is accompanied by fun virtual reality content, easy for children to use, and has the potential to broaden access for a larger number of people suffering from myopia. The MyopiaX® app administers an intervention that targets the eye’s innate growth mechanisms using blue light delivered to the optic nerve head. The MyopiaX-1 study is designed to provide the first clinical insight into the effects of MyopiaX®, and we are very pleased to have reached this important milestone with the completion of the trial enrollment,” he added.
During the ongoing MyopiaX-1 trial, Dopavision is dedicated to continually generating additional scientific and clinical evidence to enhance the effectiveness of MyopiaX® for all users and stakeholders.