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Updated: May 5, 2026
Intense Pulsed Light for the Treatment of Dry Eye Owing to Meibomian Gland Dysfunction
Published on: April 1, 2019
Effectiveness and safety of a novel crosslinked hyaluronate canalicular gel occlusive device for dry eye
Mark Packer1, Richard Lindstrom, Vance Thompson
1From Packer Research Associates, Inc., Fort Collins, Colorado (Packer); Minnesota Eye Consultants, Bloomington, Minnesota (Lindstrom); Vance Thompson Vision, Sioux Falls, South Dakota (Thompson); The New York Eye & Ear Infirmary, New York, New York, Icahn School of Medicine at Mt Sinai, New York, New York (Parekh); Triangle Eye Consultants, Raleigh, North Carolina (Gupta); Warrenville EyeCare and LASIK, Warrenville, Illinois (Nijm); New York University Medical Center, New York, New York (Donnenfeld).
Purpose:
To evaluate the effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared with a commercially available hydrogel canalicular plug (Form Fit).
Setting:
5 sites in the United States.
Design:
Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug).
Methods:
Adults (≥22 years) with the Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was noninferiority of the mean within subject change from baseline to month 3 in Schirmer score for patients receiving filler compared with plugs. The key secondary effectiveness endpoint was noninferiority of the proportion of patients with filler achieving improvement from baseline to month 3 in OSDI by a minimal clinically important difference. Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear breakup time, and safety.
Results:
157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was noninferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI.
Conclusions:
Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.
