Efficacy Of Crosslinked Hyaluronate Canalicular Filler Vs. A Hydrogel Canalicular Plug For Dry Eye Management In Post-Ocular Surgery Patients: Insights From The Half Dome Trial.

Studies have shown a higher incidence of dry eye disease (DED) symptoms, tear film instability, and reduced tear production following certain ocular surgeries^2,3. In the HaLF DOME trial¹, a crosslinked hyaluronic acid (HA) canalicular filler (Lacrifill Canalicular Gel), was non-inferior to the hydrogel plug (Form Fit) in relieving DED symptoms, reflected in improved Schirmer and OSDI scores from baseline. This sub-analysis compares the efficacy of Lacrifill, compared to Form Fit, in patients with dry eye disease who have undergone previous ocular surgery (POS), defined as cataract/refractive surgery >6 months before treatment. This will further clarify the efficacy of crosslinked HA in treating dry eye disease post-ocular surgery.

A multicentre, randomized, prospective, controlled, double-masked clinical study across 5 sites in the United States.

This sub-analysis evaluates Schirmer test scores and adverse events obtained from the previously published HaLF DOME trial, focusing on the proportion of participants who had previously undergone cataract (n=25/49) and/or refractive (n=26/49) surgery. Inclusion criteria for this study were: adults (≥22 years) with a Schirmer test (with anaesthesia) result of ≤10 mm/5 minutes and an OSDI score of ≥23. Patients who had undergone ocular surgery more than 6 months prior were included in the trial. Participants were randomly assigned 2:1 to receive bilateral insertion of crosslinked HA filler or hydrogel plug into the inferior canaliculi.

49 patients, with POS, completed the study: 14 treated with the hydrogel plug and 35 with HA filler. After 3 months, those treated with HA filler showed a mean improvement of 4.76mm from baseline Schirmer score compared with 3.34mm in those treated with the hydrogel plug.

After 6 months, POS patients in the HA filler arm maintained their mean improvement in Schirmer score from baseline, at 4.91mm, while those treated with the hydrogel plug saw their mean improvement from baseline Schirmer score drop to 1.68mm.

A similar rate of patients with ≥1 ocular device-related AEs was observed in POS patients treated with HA filler (28.6%, 10/35) compared with the hydrogel plug (21.4%, 3/14). Superiority was not confirmed by statistical analysis.

Lacrifill crosslinked HA filler was statistically non-inferior to the hydrogel plug in reducing dry eye symptoms in post-ocular surgery patients. However, when compared to patients treated with the hydrogel plug, a trend towards a greater improvement from baseline Schirmer score at both 3 and 6 months post-Lacrifill administration was observed. A similar reduction from baseline OSDI score at 3 months, was also seen in the post-ocular surgery cohort receiving Lacrifill compared to hydrogel plugs. These trends warrant further investigation. Alongside the HaLF DOME trial, this sub-analysis demonstrates Lacrifill crosslinked HA filler to be a well-tolerated, effective treatment for dry eye disease in post-ocular surgery patients.