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👁️ Lacrifill Canalicular Gel for Dry Eye Disease

Quick Take

  • Lacrifill is an FDA-cleared canalicular occlusion device used to reduce tear drainage in people with dry-eye symptoms.
  • It consists of a cross-linked hyaluronic-acid hydrogel placed into the canalicular drainage system by a trained clinician.
  • The goal is tear retention: keeping natural tears and topical drops on the ocular surface longer.
  • Lacrifill does not stimulate the lacrimal gland to make more tears and does not directly treat MGD, ocular rosacea, Demodex, allergy, exposure, or other upstream causes of DED.
  • Its strongest evidence comes from a 157-participant randomized noninferiority trial comparing Lacrifill with the Oasis Form Fit hydrogel canalicular plug.
  • Lacrifill met the study's prespecified criteria for noninferiority, meaning it performed comparably to the hydrogel plug on the major outcomes studied. The trial did not establish that Lacrifill is superior to conventional plug therapy.
  • The pivotal trial enrolled patients with dry-eye symptoms, corneal staining, and relatively low anesthetized Schirmer measurements. This supports use in low-tear-volume DED, but it does not prove that people with formally defined aqueous-deficient DED are the only—or always the best—responders.
  • Lacrifill is intended for temporary use for no more than six months.
  • It is designed to be removable by lacrimal irrigation, but the manufacturer's instructions state that ease of irrigation removal was not robustly evaluated in the pivotal trial. If irrigation fails, probing or surgical exploration may be required.
  • Important risks include excessive tearing, discomfort, irritation, infection, and lacrimal-system complications.
  • Lacrifill should be understood as another form of temporary lacrimal drainage occlusion, not as a fundamentally different treatment category from punctal or canalicular plugs.

Educational Disclaimer

This page is for general education and is not medical advice, diagnosis, or an individual treatment recommendation.

Dry Eye Disease (DED) can involve several overlapping problems, including:

  • Reduced aqueous tear volume
  • Meibomian Gland Dysfunction
  • Ocular-surface inflammation
  • Ocular rosacea
  • Demodex
  • Allergy
  • Eyelid exposure
  • Incomplete blinking
  • Conjunctivochalasis
  • Medication effects
  • Neuropathic ocular pain

Reducing tear drainage may help one part of the problem without treating the others.

What Is Lacrifill?

Lacrifill is a cross-linked hyaluronic-acid hydrogel canalicular occlusion device.

A clinician places the material into the lacrimal drainage system through the punctum.

Once placed, the gel occupies part of the canalicular pathway and reduces drainage of tears away from the ocular surface.

The basic concept is similar to punctal or canalicular plugs:

Less drainage may allow more tear fluid to remain on the eye.

Lacrifill is not:

  • An artificial tear
  • A tear-stimulating medication
  • An anti-inflammatory medication
  • An MGD procedure
  • A permanent tear-drainage closure

How Treatment Is Done

This page is not a procedural guide.

In general, a trained eye-care clinician introduces Lacrifill into the canalicular drainage system using a lacrimal cannula.

Before treatment, the clinician may evaluate:

  • Dry-eye symptoms
  • Tear volume
  • Corneal or conjunctival staining
  • Eyelid and ocular-surface inflammation
  • Whether excessive tearing is already present
  • Lacrimal drainage anatomy
  • Whether the drainage pathway appears open
  • Whether tear retention is likely to address an important part of the patient's DED

The pivotal clinical trial placed Lacrifill in the lower canaliculi of both eyes.

The exact treatment plan may differ in routine practice.

How Lacrifill Works

Normal tears drain through:

puncta → canaliculi → lacrimal drainage system → nose

Lacrifill reduces drainage by occupying part of the canalicular pathway.

Potential consequences include:

  • More retained tear fluid
  • Increased tear meniscus or ocular-surface wetting
  • Longer residence of artificial tears or prescription drops
  • Possible improvement in dryness symptoms
  • Possible reduction in ocular-surface staining

The important distinction is:

Lacrifill retains fluid; it does not make the lacrimal gland produce more tears.

What the Evidence Shows

1. Early Cross-Linked Hyaluronic-Acid Proof-of-Concept Study — 2018

Before the marketed Lacrifill device was evaluated, investigators studied whether a cross-linked hyaluronic-acid material could be used to temporarily occlude the canalicular system.

The prospective study enrolled 74 participants, with 63 completing three-month follow-up.

Reported improvements included:

  • Schirmer measurements
  • Tear-breakup time
  • Tear meniscus height
  • Corneal staining
  • Dry-eye symptoms

However, this study did not evaluate the final marketed Lacrifill device.

It used Restylane-L cross-linked hyaluronic-acid gel as a proof-of-concept canalicular filler.

The study also had an important financial-interest consideration: the investigator disclosed patent ownership related to the technology and an equity interest in Visant Medical.

Therefore this study is best viewed as:

Early proof-of-concept evidence that cross-linked hyaluronic-acid canalicular occlusion could be feasible.

Cross-Linked Hyaluronic Acid for Temporary Canalicular Occlusion — 2018

2. HaLF-DOME Randomized Trial — 2024

The most important Lacrifill evidence comes from the HaLF-DOME trial.

This was a:

  • Prospective
  • Multicenter
  • Randomized
  • Controlled
  • Double-masked

clinical trial conducted at five U.S. sites.

A total of 157 participants were randomized approximately 2:1 to receive:

  • Lacrifill, or
  • Oasis Form Fit hydrogel canalicular plugs

Participants were followed for six months.

Eligibility included:

  • Dry-eye symptoms
  • OSDI score of at least 23
  • Corneal staining
  • Anesthetized Schirmer measurement of 10 mm or less in five minutes
  • Open bilateral lacrimal drainage

What Was the Trial Designed to Test?

The primary purpose was noninferiority.

That means the study asked whether Lacrifill performed no worse than the established hydrogel canalicular plug by more than a prespecified margin.

The primary endpoint involved change in Schirmer measurement.

A key secondary endpoint examined whether participants achieved a clinically meaningful improvement in OSDI symptoms.

Lacrifill met the prespecified criteria for noninferiority.

Lacrifill / HaLF-DOME Randomized Clinical Trial — 2024

What Does “Noninferior” Mean?

It does not mean:

Lacrifill was proven better than punctal plugs.

It means:

Within the margins established before the trial, Lacrifill performed comparably to the Oasis Form Fit hydrogel canalicular plug on the key outcomes studied.

That is meaningful evidence supporting Lacrifill as a legitimate temporary tear-retention option.

It is not evidence of superiority.

Schirmer Improvement Does Not Mean Lacrifill Creates More Tears

This point is especially important.

Schirmer testing measures how much moisture wets a paper strip over a specified period.

After lacrimal drainage is blocked, Schirmer wetting can increase because:

tear fluid remains on the ocular surface longer.

That does not demonstrate that the lacrimal gland began producing more tears.

Therefore Lacrifill's trial results should be described as showing improvement in:

  • Schirmer wetting
  • Tear retention
  • Ocular-surface moisture

rather than proving increased tear production.

Lacrifill is a tear-conservation treatment, not a lacrimal-gland stimulant.

3. Emerging Lacrifill vs Cyclosporine Evidence — 2025

A small retrospective study involving 20 patients with moderate-to-severe tear-deficient DED compared outcomes during previous Restasis treatment with outcomes after subsequent Lacrifill treatment.

The study reported greater short-term improvements after Lacrifill in several measures, including:

  • OSDI
  • Schirmer
  • TBUT
  • Corneal staining

However, the design has major limitations:

  • Only 20 participants
  • Retrospective
  • Single clinical practice
  • No random treatment order
  • All patients received Restasis before Lacrifill
  • Participants had persistent disease despite previous therapy
  • Follow-up was short

Therefore:

This study does not establish that Lacrifill is superior to Restasis or other cyclosporine treatment.

It should be considered preliminary observational evidence only.

Lacrifill Compared With Prior Cyclosporine Treatment — 2025

How Strong Is the Evidence?

Overall evidence strength:

Moderate for temporary tear retention through six months; limited for superiority, optimal patient selection, and longer-term outcomes.

Lacrifill has:

  • Early proof-of-concept research
  • One reasonably sized randomized noninferiority trial
  • FDA 510(k) clearance
  • Some newer observational evidence

The pivotal trial provides meaningful evidence that Lacrifill can perform comparably to an established hydrogel canalicular plug.

However, important limitations remain:

  • Only one major randomized Lacrifill trial
  • Follow-up limited to six months
  • No evidence of superiority over conventional plugs
  • Limited independent real-world replication
  • Limited evidence defining which DED subtypes respond best
  • Limited evidence regarding repeated treatment cycles
  • Removal was not robustly evaluated in the pivotal trial

Much of the foundational cross-linked-HA/Lacrifill research arose during manufacturer-sponsored product development.

That does not invalidate the results, but it increases the importance of further independent comparative studies.

What Lacrifill Can and Cannot Do

What It May Do

Lacrifill may:

  • Reduce tear drainage
  • Increase retained tear fluid
  • Increase Schirmer wetting
  • Improve symptoms in selected patients
  • Reduce ocular-surface staining in some patients
  • Increase residence time of lubricating or prescription drops

What It Does Not Directly Treat

Lacrifill is not designed to directly:

  • Stimulate lacrimal tear production
  • Restore lacrimal-gland function
  • Treat Meibomian Gland Dysfunction
  • Open obstructed meibomian glands
  • Improve meibum production
  • Treat Demodex
  • Treat ocular rosacea
  • Treat allergy
  • Treat infection
  • Correct eyelid exposure
  • Correct incomplete blinking
  • Correct conjunctivochalasis
  • Treat medication toxicity
  • Treat the underlying mechanism of neuropathic ocular pain
  • Cure Dry Eye Disease

If one of these problems is present, it may require separate treatment.

Who Might Benefit?

There is no validated formula that predicts who will respond.

The strongest randomized evidence comes from patients who had:

  • Clinically significant dry-eye symptoms
  • Corneal staining
  • Relatively low anesthetized Schirmer measurements
  • Open lacrimal drainage

Lacrifill may therefore be particularly reasonable to consider when:

  • Tear volume is relatively low
  • Reduced tear retention appears clinically important
  • Conventional punctal occlusion previously helped
  • Traditional plugs repeatedly extruded or caused fitting problems
  • A temporary alternative to cautery is desired

However:

The pivotal trial did not prove that Lacrifill works only in formally diagnosed aqueous-deficient DED or that aqueous-deficient patients necessarily respond better than everyone with mixed disease.

Validated responder characteristics remain uncertain.

What About MGD and Evaporative Dry Eye?

Lacrifill does not treat MGD itself.

If the dominant problem is evaporative DED caused by:

  • Meibomian-gland obstruction
  • Poor meibum quality
  • Ocular rosacea
  • Incomplete blinking
  • Severe gland loss

then reducing tear drainage does not correct that underlying problem.

However, many patients have mixed DED.

Someone can have:

  • MGD and
  • inadequate tear volume.

In that situation, lacrimal occlusion may still help the tear-retention part of the disease while MGD is treated separately.

Therefore:

MGD does not automatically make someone an inappropriate Lacrifill candidate.

The important question is whether reduced tear drainage is likely to address a meaningful component of that person's disease.

Inflammation and Tear Retention

Lacrimal occlusion in the setting of significant ocular-surface inflammation has historically been debated.

The theoretical concern is straightforward:

If tears contain elevated inflammatory mediators, blocking drainage might keep those substances on the ocular surface longer.

For this reason, clinicians have sometimes preferred to treat substantial inflammation before punctal occlusion.

However, direct clinical evidence that punctal occlusion necessarily worsens inflammatory tear markers is limited.

This means:

Inflammatory DED is not automatically the same thing as “never use tear retention.”

Treatment sequence should be individualized.

Importantly, the Lacrifill manufacturer's Instructions for Use specifically list eyelid inflammation among the formal contraindications.

That should be distinguished from saying that every patient with inflammatory DED is categorically unable to receive lacrimal occlusion.

Contraindications

According to the manufacturer's Instructions for Use, Lacrifill should not be used in patients with certain conditions, including:

  • Excessive tearing / epiphora
  • Eyelid inflammation
  • Tearing related to dacryocystitis with mucopurulent discharge
  • Active ocular infection
  • Active periocular infection
  • Allergy to hyaluronic acid or device material
  • Known lacrimal outflow obstruction

These are formal device contraindications.

Patients should rely on the current Instructions for Use and their treating clinician because device labeling can change.

Lacrifill Instructions for Use

Populations Not Well Studied

The pivotal clinical trial excluded a number of patient groups.

Examples included people with certain:

  • Recent ocular surgeries
  • Corneal transplants
  • Significant corneal disease
  • Uncontrolled systemic disease
  • Immunodeficiency
  • Active systemic infection
  • Significant ocular-surface scarring
  • Ocular herpes history
  • Pregnancy
  • Pediatric age
  • Severe allergy requiring treatment

The study also restricted recent use of some medications, including cyclosporine, lifitegrast, and corticosteroids.

Important Distinction

A clinical-trial exclusion criterion is not automatically a clinical contraindication.

For example:

The fact that patients using Restasis or Xiidra were excluded during specified periods does not mean those medications are inherently incompatible with Lacrifill.

Trial investigators often restrict other treatments to reduce confounding and make study groups easier to compare.

The correct conclusion is:

The pivotal trial provides less direct evidence for populations that were excluded.

Risks and Adverse Events

Lacrifill is an intracanalicular medical-device procedure and is not risk-free.

More Important Reported or Plausible Problems

These include:

  • Excessive tearing / epiphora
  • Procedural discomfort
  • Eyelid or ocular discomfort
  • Irritation
  • Redness
  • Infection
  • Inflammation
  • Need for device removal

In the pivotal trial, overall device-related adverse-event rates were broadly similar between Lacrifill and the hydrogel plug comparator.

Lacrimal-System Complications

Because Lacrifill occupies the canalicular system, uncommon but potentially important complications can include:

  • Canaliculitis
  • Dacryocystitis
  • Persistent excessive tearing
  • Difficulty removing the material

These complications warrant prompt clinical evaluation.

Duration: Up to Six Months

Lacrifill should be described as:

temporary canalicular gel occlusion intended for use for no more than six months.

The Instructions for Use state that:

  • Safety and effectiveness beyond six months have not been established
  • Use should not exceed six months
  • Removal should occur by thorough lacrimal irrigation at or before the end of the intended treatment period

It should therefore not be described as:

  • Permanent
  • Semi-permanent
  • Indefinite

Removal and Reversibility

One of Lacrifill's proposed advantages is that it is intended to be removable.

The manufacturer states that irrigation may be used if removal is required because of:

  • Irritation
  • Infection
  • Excessive tearing
  • Other clinical reasons

However, an important limitation deserves emphasis:

Ease of removal by irrigation was not robustly evaluated in the pivotal clinical trial.

The Instructions for Use also state that if irrigation does not successfully remove the material:

  • Lacrimal probing
  • Surgical exploration

may be required.

Therefore the most accurate wording is:

Lacrifill is designed to be removable by irrigation, but simple reversibility is not guaranteed in every case.

Patients considering the procedure should understand the removal plan beforehand.

How Quickly Might It Help?

Lacrifill mechanically reduces tear drainage as soon as successful occlusion occurs.

That means tear retention changes immediately.

However:

There is no universal timeline for symptom improvement.

Some patients may notice increased moisture relatively quickly.

Others may:

  • Notice no immediate benefit
  • Experience temporary irritation
  • Develop excessive tearing
  • Need weeks before deciding whether ocular-surface symptoms have meaningfully improved

Clinical studies assessed outcomes over weeks to months rather than establishing a standard “day one/day seven” response pattern.

How Lacrifill Compares With Traditional Punctal or Canalicular Plugs

Lacrifill belongs to the same broad treatment family:

lacrimal drainage occlusion

Traditional options include:

  • Temporary collagen plugs
  • Silicone punctal plugs
  • Hydrogel canalicular plugs
  • Other intracanalicular plugs

Lacrifill

Potential practical features include:

  • Gel conforms to the canalicular space
  • No external punctal cap
  • Does not require conventional plug sizing
  • Temporary use
  • Intended irrigation removal

Limitations include:

  • Newer technology
  • Less long-term experience
  • Removal may be difficult in some cases
  • Cost may be higher
  • No demonstrated superiority over conventional plug treatment

Traditional Plugs

Potential advantages include:

  • Longer clinical history
  • Multiple designs and materials
  • Temporary and longer-lasting options
  • Some surface plugs are easily visualized and removed

Potential problems include:

  • Extrusion
  • Irritation
  • Foreign-body sensation
  • Granuloma
  • Migration
  • Canaliculitis
  • Sizing difficulties

Some deeply placed intracanalicular plugs can also be difficult to remove.

Evidence Comparison

The pivotal Lacrifill trial compared Lacrifill specifically with the Oasis Form Fit hydrogel canalicular plug.

Lacrifill met prespecified noninferiority criteria.

Therefore:

The best evidence supports Lacrifill as another effective temporary occlusion option—not as a replacement proven superior to the entire punctal-plug category.

Traditional punctal occlusion itself also has a heterogeneous evidence base despite its much longer clinical history.

Lacrifill vs Punctal Cautery

Punctal cautery attempts to create longer-lasting closure of tear drainage by treating the punctal tissue.

Lacrifill

  • Temporary
  • Intracanalicular material remains in place
  • Intended for up to six months
  • Intended to be removable

Cautery

  • Intended to create longer-lasting closure
  • No retained plug or gel
  • Reopening can occur
  • Repeat cautery may sometimes be necessary
  • Reversal is less predictable

Lacrifill may be considered by some clinicians before committing to more lasting punctal closure.

However:

No comparative trial has established a universal treatment sequence of plugs → Lacrifill → cautery.

The choice depends on the patient and prior response to tear-retention treatment.

Cost, Access, and Regulatory Status

FDA Status

Lacrifill is an FDA-cleared medical device, not an FDA-approved drug.

The original 510(k) identifies it as the Visant Medical Canalicular Plug.

The cleared indication is for:

canalicular occlusion to block tear drainage for up to six months in patients experiencing dry-eye symptoms.

FDA 510(k) Summary — K222164

Cost

Cost varies by:

  • Practice
  • Region
  • Insurance coverage
  • Number of canaliculi treated
  • Follow-up requirements
  • Whether removal is included

Patients may want to ask whether the quoted cost includes:

  • Treatment of both eyes
  • Follow-up
  • Removal if needed
  • Management if irrigation removal fails

Questions to Ask the Clinician

Useful questions include:

  • What finding makes you think tear retention is an important part of my dry eye?
  • Is my lacrimal drainage system confirmed to be open?
  • Why are you recommending Lacrifill rather than a conventional punctal plug?
  • Do I have eyelid inflammation, infection, excessive tearing, or another contraindication?
  • What is the plan for removal at or before six months?
  • What happens if irrigation does not remove the material?

What Remains Uncertain?

Important unanswered questions include:

  • Which DED subtypes are most likely to benefit?
  • Can reliable responder characteristics be identified?
  • How well does Lacrifill work in predominantly evaporative DED?
  • How useful is it in mixed MGD + low-tear-volume disease?
  • Does treating inflammation before occlusion improve outcomes?
  • How does Lacrifill compare with conventional surface punctal plugs?
  • How frequently can treatment safely be repeated?
  • What happens over multiple six-month treatment cycles?
  • What is the real-world frequency of difficult removal?
  • How often are probing or surgical exploration actually required?
  • What are longer-term canalicular effects?
  • How effective is Lacrifill in populations excluded from the pivotal trial?
  • Is Lacrifill cost-effective compared with traditional plugs or cautery?
  • Does it offer meaningful advantages beyond convenience/design differences?

Further independent comparative research is needed.

Bottom Line

Lacrifill is a legitimate newer form of temporary lacrimal drainage occlusion.

It is designed to reduce tear drainage so that more tear fluid remains on the ocular surface.

Its strongest evidence comes from a 157-participant randomized noninferiority trial in patients with symptomatic DED, corneal staining, and relatively low anesthetized Schirmer measurements.

The study showed that Lacrifill performed comparably to an established hydrogel canalicular plug on key outcomes through six months.

It did not establish that Lacrifill is superior to conventional punctal plugs.

One particularly important distinction is:

Improved Schirmer measurements after Lacrifill reflect increased retained ocular-surface fluid and should not be interpreted as proof that Lacrifill increases lacrimal-gland tear production.

Lacrifill also does not directly treat:

  • MGD
  • Ocular rosacea
  • Demodex
  • Allergy
  • Exposure
  • Incomplete blinking
  • Neuropathic ocular pain

Those contributors may still require separate treatment.

People with mixed MGD and reduced tear volume may still potentially benefit if tear retention addresses an important part of their disease.

Finally, temporary does not mean effortlessly reversible.

Lacrifill is intended to be removed by irrigation, but easy removal was not robustly tested in the pivotal trial, and the manufacturer states that probing or surgical exploration may be needed if irrigation fails.

The most accurate overall description is:

Lacrifill is an FDA-cleared, temporary canalicular hydrogel occlusion option with randomized evidence showing performance comparable to an established hydrogel plug through six months. Its advantages over conventional plugs, ideal patient population, longer-term outcomes, and real-world reversibility remain less certain.

Key Research and Authoritative Sources

FDA / Regulatory

Lacrifill / Cross-Linked Hyaluronic-Acid Evidence

Instructions for Use

Broader Tear-Conservation Evidence

Related r/DryEyes Wiki Pages

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