A recent study evaluated the safety and efficacy of a novel crosslinked hyaluronate canalicular filler for the treatment of dry eye disease. The study compared this filler—Lacrifill Canalicular Gel—with Form Fit, a commercially available hydrogel plug, in a randomized, double-masked trial with 157 patients. Of the enrolled patients, 65% were postmenopausal, 83% had severe dry eye, and 37% had a history of LASIK and/or cataract operation.
While can be effective, they are also limited. Patients may still experience only transient symptom relief when using topical treatments, and prescription pharmaceuticals, or modifying environmental factors that contribute to dry eye. Additionally, these remedies can present challenges from installation procedures, costs, and use of preservatives.
“AAO and members of the Tear Film and Ocular Surface Society Dry Eye Workshop II recommend tear conservation through lacrimal occlusion as a second-line treatment option for managing dry eye,” the researchers wrote in their article, published in the Journal of Cataract and Refractive Surgery. “[These] devices improve dry eye by reducing tear outflow resulting in increased ocular surface moisture and are convenient for the patient.”
The crosslinked hyaluronate (HA) filler device in this study is designed to occlude the canalicular system in order to block tear drainage. The FDA-approved device is indicated for use up to 6 months. Consisting of a gel-like material, it fills the lumen to prevent tear flow through the lacrimal drainage system. It is convenient for patients because it doesn't require custom sizing, and irrigating the canaliculus removes the material.
The investigators found that the crosslinked HA filler was noninferior to the hydrogel plug. It showed improvements not only in Schirmer scores, but also in ocular surface disease index (OSDI) scores with 84.3% of patients using the HA filler showing clinically significant OSDI improvements. Significant improvements in tear breakup time were also observed in both treatment groups, though the HA filler group showed slightly better results at 12 and 24 weeks.
Further, the crosslinked HA filler demonstrated higher retention rates in the canaliculus over six months compared with the hydrogel plug, which may contribute to longer-lasting relief in dry eye patients, the investigators noted. Patient satisfaction scores were higher in the group treated with the HA filler, with fewer reports of discomfort or foreign body sensation. Both groups exhibited similar rates of adverse events, and the HA filler was well tolerated with no serious safety concerns.
“The crosslinked HA filler will be useful in a wide population of patients with dry eye, including those undergoing cataract and refractive surgery,” the investigators concluded.
A full list of author disclosures can be found in the published research.
