Lacrifill^® Canalicular Gel is a new and 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.

What is Lacrifill Canalicular Gel?

Lacrifill^® is a sterile, colourless gel composed of cross-linked, non-animal hyaluronic acid. It is supplied in a pre-filled syringe and is available in boxes of 10. Lacrifill^® is designed to temporarily block tear drainage by the occlusion of the lacrimal canaliculus of one or both eyelids in a given patient, thus maintaining lubricating tears on the surface of the eye.¹ Lacrifill^® is intended for use, for up to 6 months, in adult patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations, which can be relieved by blocking of the canalicular system.¹

What is the shelf-life of Lacrifill and does it need to be stored in a fridge?

Lacrifill^® has a shelf life of 36 months. Lacrifill^® must be used prior to the expiration date on the package. Store at a temperature of +5ºC up to +25ºC. Protect from sunlight. Refrigeration is not required.¹

Is the cannula provided with Lacrifill?

Each box of 10 Lacrifill pre-filled syringes comes with a 10 pack of 25 gauge straight cannulas to allow for easy use.¹

Is Lacrifill preservative free?

Lacrifill does not contain any preservatives.¹

Is Lacrifill non-allergenic?

Lacrifill^® is considered non-allergenic. Lacrifill is contraindicated for patients who are allergic to Hyaluronic acid.¹

How much gel is provided in each syringe of Lacrifill?

Lacrifill^® comes in a pre-filled syringe with 0.6ml of gel, containing enough gel to fully fill both inferior canaliculi of a single patient. Each syringe of Lacrifill is for single patient use only.¹

How much of the gel should I be using per eye?

Each pre-filled syringe of Lacrifill contains 0.6ml of gel. This is to allow 0.1ml to prime the syringe and deliver 0.2ml of gel into the patients inferior canaliculus before repriming with another 0.1ml and filling the other inferior canaliculus with another 0.2 ml of gel.¹

Can Lacrifill easily be removed? How?

Yes, Lacrifilll can be easily removed via saline irrigation. To remove the gel, irrigate the gel from the canaliculus using a syringe filled with sterile saline. Attach a lacrimal cannula onto the syringe, insert the cannula into the canaliculus, and gently irrigate until Lacrifill^® is removed from the canaliculus as evidenced by free flow of fluid through the lacrimal drainage system and/or the patient’s report of swallowing or a fluid sensation in the nose or throat.¹

Do I need to irrigate before administering Lacrifill?

The Lacrifill instructions for use states that it is necessary to irrigate the caniliculus prior to Lacrifill to ensure that it is patent. Punctal irrigation must demonstrate good lacrimal drainage prior to insertion of Lacrifill^®.¹

Do I need to apply topical anaesthetic before administering Lacrifill?

Prior to punctal irrigation and insertion of Lacrifill^®, a topical anesthetic agent should be instilled in the conjunctival sac for patient comfort and to slow down their blink rate.¹

Who can administer Lacrifill?

Lacrifill^® can only be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law, typically ophthalmologists or optometrists. 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.

Are there any types of patient I should avoid using Lacrifill with?

Lacrifill^® is contraindicated for patients with lacrimal outflow obstruction, inflammation of the ocular surface not associated with dry eye, active ocular or periocular infection (for example, dacryocystitis, canaliculitis, conjunctivitis, keratitis) and those who are allergic to hyaluronic acid.¹

Do I need to be trained in order to administer Lacrifill?

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

What evidence is available to show the effectiveness of Lacrifill?

The efficacy and safety of Lacrifill was evaluated over 6 months in a randomised clinical trial. The HaLF-DOME study was a prospective, multicenter, controlled, double-masked, randomised study to evaluate the efficacy and safety of Lacrifill^® in treating chronic DED compared to Oasis Form Fit canalicular plugs.²

Are there any known side effects to Lacrifill?

Potential undesirable side effects include: (Eyelid) pain, Allergic reactions, Blepharitis, Canaliculitis, Conjunctivitis, Corneal ulceration, Dacryocystitis, Distal migration, Epiphora, Foreign Body Sensation, Itching, Local infection, Local irritation, Loss / Partial extrusion, Punctal granuloma and Swelling.¹

How long does Lacrifill last for?

Lacrifill has shown to be effective at blocking the canalicular system to relieve dry eye symptoms for up to 6 months.²

How long untill it will start to take effect?

The HaLF-DOME study demonstrated Lacrifill to improve ocular surface health from baseline to day 7, indicated by a significant improvement in Corneal Staining, which was sustained for 6 months.³

What types of patients/demographics featured in the HaLF-DOME trial?

Both treatment groups in the HaLF DOME trial had similar demographics and baseline characteristics. Including ocular medical history of meibomian glad dysfunction (19.7%), blepharitis (8.3%), LASIK (16.6%) and Cataract surgery (15.9%). Patients presented with moderate-severe DED, as reflected in mean anaesthesised Schirmer scores of 5.39mm for LF (Lacrifill), and 5.47 mm for FF (Form Fit). Mean baseline OSDI was 48.8 for LF, and 46.4 for FF.²

Are there any ongoing studies involving Lacrifill?

Yes, there are several investigator initiated trials involving Lacrifill that are ongoing. To keep up to date with the latest on these trials please refer to our resources clinical evidence section. If you are interested in conducting a clinical study involving Lacrifill please contact us and our medical team will be in touch.

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See full product details in our instructions for use

There was comparable incidence of of ocular device-related AEs between treatment groups in the pivotal clinical trial

Scroll to the right to see all data

Parameter	Lacrifill® (n=103) n (%)	Form Fit (n=54) n (%)	Total (N=157) n (%)
Number of patients with ≥1 ocular device-related AE	26 (25.2)	14 (25.9)	40 (25.5)
Most common ocular device-related AEs
Eyelid pain	5 (4.9)	1 (1.9)	6 (3.8)
Epiphora	8 (7.8)	3 (5.6)	11 (7.0)
Blepharitis	2 (1.9)	1 (1.9)	3 (1.9)
Procedural pain	7 (6.8)	3 (5.6)	10 (6.4)

N=total number of patients in the respective treatment group. Percentages were based on the total number of patients in each treatment group. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) 23.1. Patients experiencing >1 AE were counted once within that preferred term. Device-related AEs were those categorised as definite, probable, and possible.

Adapted from: Packer M, et al. 2024.¹

Explore the half dome study

Lacrifill is contraindicated for the following patients¹

With lacrimal outflow obstruction
With inflammation of the ocular surface not associated with dry eye
With active ocular or periocular infection
Allergic to hyaluronic acid

Qualitative and quantitive components of Lacrifill Canalicular Gel¹

Ingredients	Content per g
Crosslinked sodium hyaluronate	20 mg
Sodium chloride	9 mg
Potassium dihydrogen phosphate, KH₂PO₄	0.02 mg
Disodium hydrogen phosphate dihydrate, Na₂HPO₄ · 2H₂O	0.22 mg
Water for Injection (WFI)	ad 1g

FAQ and product details

What is Lacrifill Canalicular Gel?

What is the shelf-life of Lacrifill and does it need to be stored in a fridge?

Is the cannula provided with Lacrifill?

Is Lacrifill preservative free?

Is Lacrifill non-allergenic?

How much gel is provided in each syringe of Lacrifill?

How much of the gel should I be using per eye?

Can Lacrifill easily be removed? How?

Do I need to irrigate before administering Lacrifill?

Do I need to apply topical anaesthetic before administering Lacrifill?

Who can administer Lacrifill?

Are there any types of patient I should avoid using Lacrifill with?

Do I need to be trained in order to administer Lacrifill?

What evidence is available to show the effectiveness of Lacrifill?

Are there any known side effects to Lacrifill?

How long does Lacrifill last for?

How long untill it will start to take effect?

What types of patients/demographics featured in the HaLF-DOME trial?

Are there any ongoing studies involving Lacrifill?

There was comparable incidence of of ocular device-related AEs between treatment groups in the pivotal clinical trial

Lacrifill is contraindicated for the following patients¹

Qualitative and quantitive components of Lacrifill Canalicular Gel¹

To view the Lacrifill^® instructions for use please click here.

Adverse events should be reported

Welcome

FAQ and product details

There was comparable incidence of of ocular device-related AEs between treatment groups in the pivotal clinical trial

Lacrifill is contraindicated for the following patients1

Qualitative and quantitive components of Lacrifill Canalicular Gel1

Adverse events should be reported

Welcome

Lacrifill is contraindicated for the following patients¹

Qualitative and quantitive components of Lacrifill Canalicular Gel¹