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Most common adverse event reported (treatment vs. control): Headaches (14.3% vs. 1.7%), all graded as mild and transient
Cases of new or worsening eye-turn were balanced between groups (7.1% Luminopia vs. 8.5% control)
Rate of all ocular side effects similar between groups
Safety of Luminopia in children aged 8 - 12 is expected to be in line with the safety in children aged 4 - 7.
Patients should only use Luminopia while wearing their prescribed glasses under the headset
Patients should wear Luminopia while seated or lying down.
Patients with a history of light-induced seizures, serious medical conditions, new or worsening eye-turn, or double vision should contact their doctor for additional evaluation and permission
Patients should stop using Luminopia and contact their doctor for additional evaluation if they experience worsening vision in either eye, headache, nausea, eye strain that doesn't go away after usage, dizziness, or increased night terrors