Protocol
Primary Objective:
To formally compare the effectiveness of Luminopia 1 hour / day, 6 days per week while wearing optical correction if needed versus continued optical correction alone if needed, in children 8 to 12 years of age, as a superiority test. To formally compare the effectiveness of Vivid Vision 25 minutes / day, 6 days per week while wearing optical correction if needed versus continued optical correction alone if needed, in children 8 to 12 years of age, as a superiority test. If both Luminopia and Vivid Vision are superior to continued optical correction alone if needed, then the effectiveness of Luminopia versus Vivid Vision will be formally compared in children 8 to 12 years of age, as a superiority test. If either Luminopia or Vivid Vision is NOT superior to continued optical correction alone if needed, then the treatment group difference and 95% CI for the difference between treatment groups will be calculated with no p-value and the results will be considered exploratory only. It is noted for the comparison of Luminopia versus Vivid Vision, the absence of a statistically significant difference cannot rule out the presence of a clinically meaningful difference between active treatment groups. The test is powered assuming a difference between treatments as small as 3.75 letters with a standard deviation of 7.0 letters |