Rationale for Duration of Treatment. Follow-Up The duration of exposure to the investigational product was chosen to address the objective of this study, and is aligned with the duration of use of the product in accordance with product labeling.
Rationale for Duration of Treatment. Follow-Up Follow-up period required to properly evaluate effectiveness of astigmatism reduction of IP are set up.
Rationale for Duration of Treatment. Follow-Up The duration of exposure to the contact lenses was chosen to address the objective of this study, and is aligned with MF fitting guidelines for initial fit assessment following lens insertion.
Rationale for Duration of Treatment. Follow-Up One week exposure of test and control for each subject
Rationale for Duration of Treatment. Follow-Up Subjects will wear each study product bilaterally for approximately 1 week. The primary will be assessed on approximately after 1 week of wearing each study product .
Rationale for Duration of Treatment. Follow-Up Subjects will wear the test and comparator products bilaterally for approximately 28 and 14 days, depending on the lens being dispensed. Subjects will remain masked to the lens type. The primary variable will be assessed on Day 1 and at Day 28 for test product and at Day 14 for comparator product.
Rationale for Duration of Treatment. Follow-Up The duration of exposure as well as the schedule of follow-up visits follow the recommended guidance from ISO 11980:2012 and the US FDA 510(k) guidance document.
