Efficacy Of Crosslinked Hyaluronate Canalicular Filler Vs. A Hydrogel Canalicular Plug For The Management Of Dry Eye Disease In Patients With A History Of, Or Current Mgd/Blepharitis: A Sub-Analysis Of The Half Dome Trial

Blepharitis and Meibomian Gland Dysfunction (MGD) are common co-morbidities in Dry Eye Disease (DED) patients, where inflammation, irritation, and disrupted gland function lead to tear film instability, further contributing to DED^2,3.

In the HaLF DOME trial¹, a crosslinked hyaluronic acid (HA) canalicular filler (Lacrifill), was non-inferior to the hydrogel plug (Form Fit) in relieving dry eye symptoms, shown through mean Schirmer and OSDI score improvements from baseline. This sub-analysis evaluates the efficacy of Lacrifill, compared to Form Fit, in the treatment of DED in patients with a history of, or current, MGD and/or Blepharitis, further clarify the efficacy of Crosslinked HA in treating dry eye disease in this at-risk group.

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

This sub-analysis evaluates Schirmer test scores collected in the previously published HaLF DOME trial, focusing on the proportion of patients previously diagnosed with MGD and/or Blepharitis. The trial included adults (≥22 years) with a Schirmer test result of ≤10 mm/5 minutes and an OSDI score of ≥23. Participants were randomised 2:1 to receive either crosslinked HA filler or a hydrogel plug, bilaterally inserted into the inferior canaliculi. 42 patients were included in this sub-analysis, of which 40 had active MGD/blepharitis at baseline. 29 patients were treated with HA filler and 13 with the hydrogel plug. As per the original trial, we will evaluate the change in Schirmer score at both 3 and 6 months from baseline.

The sub-analysis included 42 MGD/Blepharitis patients. At 3 months post-treatment, HA filler showed a trend towards producing a greater Schirmer’s score improvement, with a 5.6mm increase from baseline compared to the Form Fit group, showing a 2.4 mm increase from baseline. 

At 6 months, HA filler continued the trend of showing a greater improvement in Schirmer’s score in MGD/Blepharitis patients versus the hydrogel plug, with increases from baseline of  4.7 mm increase and 0.7mm respectively.

A similar rate of ≥1 ocular device-related AEs was observed in MGD/Blepharitis patients treated with HA filler (58.6%, 17/29) compared with the hydrogel plug (61.5%, 8/13).

Numerical superiority was not statistically confirmed.

Lacrifill crosslinked HA filler was statistically non-inferior to the Form Fit hydrogel plug, in improving Schirmer’s test scores in patients with MGD/Blepharitis. However, a trend towards a greater improvement in Schirmer’s test score from baseline with Lacrifill was observed at 3 and 6 months post-treatment.

Patients with MGD/Blepharitis treated with Lacrifill show a similar improvement in Schirmer’s test scores compared to the overall HaLF DOME population, lasting up to six months post-treatment. Yet, this pattern was not seen in the Form Fit arm. Further analysis is needed to confirm these trends.

Lacrifill has shown to be an effective and well-tolerated treatment for DED in patients with a history of, or active, MGD/Blepharitis.