What potential undesirable side effects are listed in the IFU?
Potential undesirable side effects include eyelid pain, allergic reactions, blepharitis, [...]
How much pain did patients report during administration?
On a scale from 1, representing no pain, to 10, [...]
What were the most commonly reported device-related adverse events?
The most commonly reported ocular device-related adverse events with Lacrifill® [...]
What proportion of Lacrifill® patients experienced an ocular device-related adverse event?
In the pivotal study, 25.2% of patients treated with Lacrifill® [...]
What safety monitoring was performed in the pivotal study?
Safety was assessed through monitoring of adverse events, corrected distance [...]
What did the study conclude?
The authors concluded that Lacrifill® was a well-tolerated and effective [...]
How easy was Lacrifill® to administer?
Investigators rated insertion difficulty on a five-point scale, on which [...]
Was Lacrifill® shown to remain in place for six months?
Dye-disappearance testing demonstrated continued lacrimal occlusion at six months. Together [...]
Were improvements maintained for six months?
Yes. Improvements from baseline in Schirmer score, OSDI, corneal staining [...]
Did patients experience a clinically meaningful improvement in symptoms?
At three months, 84.3% of patients treated with Lacrifill® achieved [...]