Protocol
Primary Objective:
To formally comparethe effectiveness of Luminopia 1 hour / day, 6 days per week while wearing opticalcorrection if needed versus continued optical correction alone if needed, inchildren 8 to 12 years of age, as a superiority test. To formally comparethe effectiveness of Vivid Vision 25 minutes / day, 6 days per week whilewearing optical correction if needed versus continued optical correction aloneif needed, in children 8 to 12 years of age, as a superiority test. If both Luminopiaand Vivid Vision are superior to continued optical correction alone if needed, thenthe effectiveness of Luminopia versus Vivid Vision will be formally compared inchildren 8 to 12 years of age, as a superiority test. If either Luminopiaor Vivid Vision is NOT superior to continued optical correction alone ifneeded, then the treatment group difference and 95% CI for the differencebetween treatment groups will be calculated with no p-value and the resultswill be considered exploratory only. It is noted for thecomparison of Luminopia versus Vivid Vision, the absence of a statisticallysignificant difference cannot rule out the presence of a clinically meaningfuldifference between active treatment groups. The test is powered assuming adifference between treatments as small as 3.75 letters with a standarddeviation of 7.0 letters |