Task Assessment Results: Actual-Use Usability Study
| Product Use Tasks | Successfully Completed Tasks | ||
|---|---|---|---|
| Retina Specialists | Assistants | Total (n = 35) | |
| Open the carton (E) | NA | 35/35 | 35/35 |
| Remove contents from carton (blister pack with PFS and USPI/IFU) (E) | NA | 35/35 | 35/35 |
| Peel the lid off the blister pack (E) | NA | 35/35 | 35/35 |
| Carefully remove the PFS using aseptic technique (E) | 23/23a | 12/12a | 35/35 |
| Snap off the PFS cap (E) | 23/23a | 12/12a | 35/35 |
| Firmly screw the needle onto the Luer lock of the PFS (E) | 23/23a | 12/12a,b | 35/35 |
| Remove needle cap (E) | 35/35 | NA | 35/35 |
| Prepare the dose by aligning the stopper with the dose line (E, SC) | 35/35 | NA | 35/35 |
| Insert PFS at injection site (E) | 35/35 | NA | 35/35 |
| Slowly inject full dose (E) | 35/35 | NA | 35/35 |
| Remove PFS from injection site (E) | 35/35 | NA | 35/35 |
| Dispose of used PFS and needle (SC) | 35/35 | NA | 35/35 |
↵a Task not assessed for some participants; users were only assessed on tasks they routinely perform.
↵b In one instance, an assistant attached an incorrect needle that was accidentally provided by the clinical study site. The incorrect needle was identified by the retina specialist and corrected properly, resulting in correct and safe product use. The incident was documented as a close call.
E = essential; IFU = instructions for use; NA = not applicable; PFS = prefilled syringe; SC = safety-critical; USPI = United States prescribing information.