Lacrifill® Canalicular Gel is an innovative CE-marked and FDA-cleared medical device for lacrimal occlusion.
It is a transparent and sterile gel made of cross-linked hyaluronic acid, intended to block tear drainage by occlusion of the canalicular system.
Lacrifill® is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms, and comes in a prefilled syringe that is sufficient for administration in both eyes of one patient.
Lacrifill® is a sterile, colourless canalicular gel composed of non-animal hyaluronic acid cross-linked with 1,4-butanediol diglycidyl ether and reconstituted in a physiological buffer. It is supplied in a pre-filled syringe containing 0.6 mL of gel.1
Lacrifill® is administered into the lower canaliculus, where it temporarily occludes the lacrimal drainage system. This reduces tear drainage and helps maintain lubricating tears on the ocular surface.1
Lacrifill® is intended for adult patients experiencing dry eye symptoms that may be relieved by occlusion of the canalicular system. These symptoms may include redness, burning, reflex tearing, itching or foreign body sensation.1
Lacrifill® is intended for use for up to six months. Its safety and effectiveness beyond six months have not been established, and the gel should be removed by thorough lacrimal irrigation after six months.1
Each Lacrifill® syringe contains 0.6 mL of gel. This provides sufficient volume to prime the cannula and administer Lacrifill® into the lower canaliculi of both eyes during the same treatment session.1
Each box of 10 Lacrifill pre-filled syringes comes with a 10 pack of 25 gauge straight cannula’s to allow for easy use.
The reason we provide a 25 gauge straight canula is because after rigorous testing of different types and sizes of canula the evidence showed that a 25 gauge straight canula was the most appropriate to withstand the extrusion force required for a steady and comfortable administration and provided the easiest application.3
Lacrifill® is supplied as a sterile pre-filled syringe and is available in boxes containing ten units.1
Lacrifill® should be stored at a temperature between 5°C and 25°C and protected from sunlight. Refrigeration is not required. The product has a shelf life of 36 months and must be used before the expiry date shown on the packaging.1
Lacrifill® does not contain any preservatives.
Lacrifill® should only be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national requirements, typically ophthalmologists or optometrists.1
Lacrifill® is provided with a 25-guage straight lacrimal cannula. However any sterile, disposable or reusable 25- to 27-gauge lacrimal cannula with a Luer-lock connection may be used at the clinicians preference. A 27-gauge cannula requires slightly greater force than a 25-gauge cannula to deliver the same amount of gel.1
A topical anaesthetic agent should be instilled into the conjunctival sac before punctal irrigation and Lacrifill® administration to support patient comfort.1
Yes. Lacrimal irrigation must demonstrate good lacrimal drainage before Lacrifill® is inserted. Lacrifill® should not be administered if the canaliculus is obstructed.1
After securely attaching the cannula to the syringe, the cannula should be primed by extruding 0.1 mL of Lacrifill® before administration into the first lower canaliculus.1
The IFU specifies administration of 0.2 mL of gel into each lower canaliculus.1
The punctum may be gently dilated when necessary to allow introduction of the lacrimal cannula.1
Yes. Gel extrusion from the upper punctum was observed in approximately one-third of administrations in the clinical study. If excess gel obscures the patient’s vision, it may be irrigated from the ocular surface.1,2
No. Lacrifill® is provided sterile for use in a single patient only. The syringe may be used to treat one or both eyes of that patient during the same session, but any unused gel must be discarded after opening.1
Lacrifill® can be removed by gently irrigating the canaliculus with sterile saline. Removal is demonstrated by free flow of fluid through the lacrimal drainage system and/or the patient reporting swallowing or a sensation of fluid in the nose or throat.1
Prior to administering Lacrifill we would strongly suggest that the healthcare professional be trained on Lacrifill administration by one of our team or another healthcare professional with experience using the product.1
Lacrifill® is intended for adults experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensation that may be relieved by blocking the canalicular system.1
No. Lacrifill® is contraindicated in patients with lacrimal outflow obstruction. Patency of the lacrimal drainage system must be confirmed before administration.1
No. Lacrifill® is contraindicated in patients with an active ocular or periocular infection, including dacryocystitis, canaliculitis, conjunctivitis or keratitis.1
Lacrifill® is contraindicated when ocular-surface inflammation is not associated with dry eye. This contraindication does not include inflammation associated with dry eye itself.1
No. Lacrifill® is contraindicated in patients with a known allergy to hyaluronic acid.1
Clinical performance has not been established in paediatric patients or in patients who are pregnant or breastfeeding.1
Clinical performance has not been established in patients who used ophthalmic cyclosporine within the previous six months or lifitegrast within the previous three months. These treatments were excluded from the pivotal study because of their potential to confound the study outcomes.1,2
As with other punctal or canalicular occlusion devices, Lacrifill® may enhance the effects of medications administered to the eye. Depending on the medication, a dosage adjustment may be required.1
Lacrifill® has been shown to provide relief from symptoms of dry eye for up to 6 months.1
Lacrifill® is intended for use in an appropriate clinical environment, including a clinic, hospital or private practice.1
Lacrifill® was evaluated in a prospective, multicentre, controlled, double-masked, randomised clinical study conducted at five sites in the United States. The study compared Lacrifill® with a commercially available hydrogel canalicular plug.2
A total of 157 patients were randomised in a 2:1 ratio to treatment with Lacrifill® or the hydrogel plug. Ninety-nine of 103 patients in the Lacrifill® group and 52 of 54 patients in the comparator group completed the study.2
Eligible patients were adults aged 22 years or older with an anaesthetised Schirmer test result of no more than 10 mm over five minutes, corneal staining, an Ocular Surface Disease Index score of at least 23, a patent lacrimal drainage system and corrected distance visual acuity of 20/40 or better in both eyes.2
The primary endpoint assessed whether Lacrifill® was non-inferior to the hydrogel plug in the mean within-patient change in anaesthetised Schirmer score from baseline to three months.2
Yes. Lacrifill® was statistically non-inferior to the hydrogel plug for change in anaesthetised Schirmer score at three months. The mean improvement from baseline was 3.9 mm with Lacrifill® and 1.9 mm with the hydrogel plug.2
At three months, 84.3% of patients treated with Lacrifill® achieved a clinically important improvement in OSDI score, compared with 83.3% of patients receiving the hydrogel plug. Lacrifill® met the predefined non-inferiority endpoint.2
Yes. Improvements from baseline in Schirmer score, OSDI, corneal staining and tear break-up time were sustained through six months in the Lacrifill® group.2
Dye-disappearance testing demonstrated continued lacrimal occlusion at six months. Together with the sustained clinical outcomes, this supported the presence and continued effect of Lacrifill® throughout the six-month study period in 100% of patients.2
Investigators rated insertion difficulty on a five-point scale, on which a lower score indicated easier insertion. Mean insertion scores for Lacrifill® were 1.8 for the right eye and 1.6 for the left eye.2
The authors concluded that Lacrifill® was a well-tolerated and effective method of treating dry eye, with clinically and statistically significant improvements, from baseline, in dry eye signs and symptoms sustained through six months.2
Safety was assessed through monitoring of adverse events, corrected distance visual acuity, biomicroscopy and intraocular pressure.2
In the pivotal study, 25.2% of patients treated with Lacrifill® experienced at least one ocular device-related adverse event, compared with 25.9% of patients receiving the hydrogel plug.2
The most commonly reported ocular device-related adverse events with Lacrifill® were epiphora in 7.8% of patients, procedural pain in 6.8%, eyelid pain in 4.9% and blepharitis in 1.9%.2
On a scale from 1, representing no pain, to 10, representing the most severe pain, mean patient-reported scores during Lacrifill® insertion were 2.2 for the right eye and 2.1 for the left eye.2
Potential undesirable side effects include eyelid pain, allergic reactions, blepharitis, canaliculitis, conjunctivitis, corneal ulceration, dacryocystitis, distal migration, epiphora, foreign body sensation, itching, local infection or irritation, loss or partial extrusion, punctal granuloma and swelling.1
