TABLE II

Summary of Operational Difficulties in the Simulated-Use Usability Study

Product Use TaskIssueNumber of ParticipantsNumber of InstancesDescription
Snap off syringe capOperational difficultyAssistant: 1/152/30Initially twisted syringe cap before snapping off
Remove injection needle capOperational difficultyRS: 1/151/30Removed injection needle during cap removal
Adjust drug doseOperational difficultyRS: 1/152/30Misunderstood plunger stopper alignment, but adjusted correct dose
  • Note: Three instances of recapping the injection needle were also observed during the study; none of these issues were specifically related to the ranibizumab prefilled syringe or instructions for use, but rather were attributable to the participant's previous experience and/or professional training or to test artifact. Therefore, they are not included in the table.

  • RS = retina specialist.