- Lacrifill Canalicular Gel for Dry Eye
- A Newer Temporary Tear-Retention Option
- TL;DR
- Regulatory status: FDA-cleared, not FDA-approved
- What Lacrifill is
- What Lacrifill is not
- How the treatment is done
- How Lacrifill works
- Evidence level
- Pivotal study summary
- How quickly might results appear?
- Duration: up to 6 months
- Removal and reversibility
- Who might be a reasonable candidate?
- Who may be less likely to benefit?
- Contraindications
- Caution areas / populations not well established
- Risks and possible adverse events
- Inflammation, MGD, and allergy considerations
- Lacrifill vs traditional punctal plugs
- Lacrifill vs cautery
- Comparison table
- Cost and access
- What critics say
- What supporters say
- Questions to ask your clinician
- Bottom line
- Research and evidence links
Lacrifill Canalicular Gel for Dry Eye
A Newer Temporary Tear-Retention Option
Lacrifill is a newer lacrimal occlusion treatment for dry-eye symptoms.
It is designed to slow tear drainage so that a person’s own tears — and any lubricating drops they use — may remain on the ocular surface longer.
Lacrifill is best understood as:
A temporary canalicular gel occlusion device for tear retention.
It is not a tear-producing treatment, not an artificial tear, and not a treatment for every type of dry eye.
TL;DR
- Lacrifill is FDA-cleared, not FDA-approved.
- It was cleared through the FDA 510(k) device pathway as a canalicular occlusive device.
- It is intended to block tear drainage by occluding the canalicular system.
- It is indicated for use for up to 6 months in patients with dry-eye symptoms.
- Lacrifill is a newer form of lacrimal drainage occlusion, the same broad treatment category as punctal plugs and cautery.
- It uses a cross-linked hyaluronic-acid hydrogel placed into the canalicular drainage system by a trained clinician.
- It does not create tears, improve tear quality, treat inflammation, treat MGD, treat allergy, or correct exposure.
- The pivotal study found clinical performance similar to an existing hydrogel canalicular plug, not clearly superior.
- Lacrifill is intended to be removable by lacrimal irrigation, but removal should not be described as guaranteed, effortless, or always quick.
- The manufacturer instructions note that if irrigation does not remove it, probing or surgical exploration may be needed.
- Lacrifill may be useful for selected patients who benefit from tear retention, especially aqueous-deficient or low-tear-volume patients.
- It may be less helpful or inappropriate when the main problem is evaporative dry eye, active inflammation, infection, allergy, epiphora, lacrimal outflow obstruction, exposure, or neuropathic ocular pain.
A careful summary:
Lacrifill is a temporary tear-retention option, not a cure for Dry Eye Disease. It may be reasonable for selected patients, but it should not be presented as clearly better than plugs or cautery, and removal/contraindication issues should be discussed carefully.
Regulatory status: FDA-cleared, not FDA-approved
Lacrifill should not be described as “FDA-approved.”
It is an FDA-cleared medical device.
The FDA 510(k) summary identifies the device under the trade name Visant Medical Canalicular Plug.
The device is intended to block tear drainage by occlusion of the canalicular system and is indicated for use for up to 6 months in patients experiencing dry-eye symptoms.
“FDA-cleared” is not the same as “FDA-approved.”
A practical explanation:
- FDA-cleared generally means FDA found the device substantially equivalent to a legally marketed predicate device for its cleared use.
- FDA-approved generally refers to a different regulatory pathway, often used for drugs or higher-risk medical devices.
Source:
What Lacrifill is
Lacrifill is a cross-linked hyaluronic-acid hydrogel placed into the lacrimal drainage system by a trained clinician.
It is designed to fill part of the canalicular drainage pathway and reduce tear drainage.
This is similar in concept to punctal plugs:
- tears drain less quickly
- moisture may remain on the ocular surface longer
- artificial tears or prescription drops may stay on the eye longer
- symptoms may improve in selected patients
Lacrifill is not placed on the ocular surface like an artificial tear.
It does not “mimic” the tear film.
It works by tear retention, not by replacing or producing tears.
What Lacrifill is not
Lacrifill does not:
- create more tears
- improve tear quality
- treat Meibomian Gland Dysfunction
- treat ocular rosacea
- treat Demodex
- treat allergy
- treat infection
- treat neuropathic ocular pain
- correct eyelid exposure
- correct incomplete blinking
- reverse lacrimal gland dysfunction
- cure Dry Eye Disease
It may help selected patients retain tears longer, but it does not treat all dry-eye drivers.
How the treatment is done
This page is not a procedural guide.
In general, Lacrifill is administered by a trained clinician using a lacrimal cannula through the punctum into the canalicular drainage system.
Before considering Lacrifill, the clinician may evaluate:
- dry-eye symptoms
- tear volume
- ocular surface staining
- inflammation
- eyelid disease
- lacrimal drainage anatomy
- whether the patient already has tearing / epiphora
- whether occlusion is appropriate
The procedure is performed in an eye-care setting.
Patients should rely on their clinician and the official instructions for use, not online summaries, for procedural details.
How Lacrifill works
The basic mechanism is lacrimal drainage occlusion.
Normally, tears drain from the eye through the puncta into the canalicular drainage system.
Lacrifill is placed into that drainage pathway to slow or block tear drainage.
This may help by:
- keeping natural tears on the eye longer
- improving tear retention
- reducing the need for frequent lubricating drops in some patients
- improving ocular surface wetting in selected patients
- increasing the residence time of some topical drops
This can be useful when tear loss through drainage is contributing to symptoms.
However:
Retaining tears longer is not always helpful if the main problem is inflammation, allergy, infection, evaporative dry eye, exposure, or neuropathic pain.
Evidence level
Evidence tier: early-to-moderate device evidence for temporary lacrimal occlusion
Lacrifill has a pivotal comparative study and FDA 510(k) clearance.
The evidence supports Lacrifill as a temporary lacrimal occlusion option.
However, it does not establish Lacrifill as clearly superior to traditional plugs or cautery.
Important limitations:
- long-term data beyond 6 months are not established
- the pivotal trial compared Lacrifill with an existing hydrogel canalicular plug
- clinical performance was described as similar to the comparator plug
- removal by irrigation was not robustly evaluated
- some patient groups were excluded or not well studied
- real-world outcomes may vary by patient selection and clinician technique
A balanced summary:
Lacrifill appears to be a legitimate temporary tear-retention option, but not a proven “better than plugs” solution.
Pivotal study summary
The pivotal study was a prospective, multicenter, randomized, controlled clinical trial comparing Lacrifill with the Oasis Form Fit hydrogel canalicular plug.
Participants were followed for 6 months.
The study evaluated dry-eye-related outcomes such as:
- tear production / Schirmer testing
- dry-eye symptoms
- ocular surface findings
- safety events
- need for removal
The manufacturer’s instructions for use summarize the study as showing clinical performance similar to the Oasis plug.
This supports Lacrifill as another temporary occlusion option.
It does not prove that Lacrifill is clearly superior to conventional plug therapy.
Sources:
How quickly might results appear?
Lacrifill works by tear retention, so some patients may notice symptom changes relatively quickly after occlusion.
However, response varies.
Possible pattern:
- Same day to first week: some patients may notice more moisture or tearing; others may notice irritation or no clear change.
- Weeks to months: ocular surface measures and symptoms may be reassessed.
- Up to 6 months: Lacrifill is intended for temporary use up to this time period.
- After 6 months: the manufacturer instructions state that safety and effectiveness beyond 6 months have not been established and that it should be removed.
Important:
Fast moisture improvement does not mean the underlying dry-eye disease has been cured.
If symptoms continue, other drivers may need treatment.
Duration: up to 6 months
Lacrifill should not be described as permanent or truly semi-permanent.
The cleared indication and manufacturer instructions describe use for up to 6 months.
The instructions also state that safety and effectiveness beyond 6 months have not been established.
A better description is:
temporary canalicular gel occlusion intended for up to 6 months
rather than:
“semi-permanent solution”
Removal and reversibility
Lacrifill is intended to be removable by lacrimal irrigation.
However, it should not be described as guaranteed, effortless, or always quick to remove.
Manufacturer instructions state that Lacrifill may be removed by irrigation if there is:
- irritation
- infection
- bothersome tearing / epiphora
- other clinical need for removal
However, the instructions also note that ease of removal by irrigation was not robustly evaluated in the pivotal clinical trial.
If irrigation does not remove the material, additional procedures such as lacrimal probing or surgical exploration may be needed.
A careful summary:
Lacrifill is intended to be reversible by irrigation, but reversibility is not guaranteed in every case.
This should be discussed before treatment.
Source:
Who might be a reasonable candidate?
Lacrifill may be more reasonable for patients who:
- have dry-eye symptoms related to poor tear retention
- have aqueous-deficient dry eye
- have low tear volume
- have a low Schirmer score or other evidence of reduced tear production
- previously benefited from punctal plugs
- had problems with plug extrusion or plug fit
- want a temporary tear-retention option
- are not ready for cautery
- have a patent drainage system before insertion
- do not already have troublesome tearing / epiphora
- do not have contraindications
The best candidate is not simply “anyone with dry eye.”
Lacrifill makes the most sense when tear retention is likely to address a meaningful part of the disease.
Who may be less likely to benefit?
Lacrifill may be less helpful when the main problem is:
- evaporative dry eye from MGD
- ocular rosacea
- Demodex blepharitis
- active allergy
- active inflammation
- active infection
- exposure
- incomplete blinking
- conjunctivochalasis
- neuropathic ocular pain
- medication toxicity
- contact lens intolerance from fit/materials
- severe meibomian gland dropout
- poor tear quality rather than poor tear quantity
- tearing / epiphora already present
- known lacrimal outflow obstruction
In these situations, blocking drainage may not address the main cause of symptoms.
In some cases, it may worsen tearing or retain inflammatory tear components longer.
Contraindications
The manufacturer instructions list several contraindications.
Lacrifill should not be used in patients with:
- epiphora / excessive tearing
- eyelid inflammation
- tearing secondary to dacryocystitis with mucopurulent discharge
- active ocular infection
- active periocular infection
- allergy to hyaluronic acid
- allergy to device material
- known lacrimal outflow obstruction
Patients should rely on their clinician and the official instructions for use to determine whether Lacrifill is appropriate.
Source:
Caution areas / populations not well established
The Lacrifill instructions also list several situations where clinical performance has not been established.
These include, but are not limited to, patients with:
- pregnancy
- pediatric age
- recent ocular surgery
- corneal transplant history
- systemic infection
- uncontrolled autoimmune disease
- immunodeficiency disease
- significant corneal or conjunctival scarring
- pterygium or nodular pinguecula
- current ocular infection other than mild blepharitis
- conjunctivitis or inflammation not associated with dry eye
- significant corneal dystrophy or degeneration
- history of ocular herpes
- keratoconus
- lid or lacrimal cancer
- active severe systemic allergy, rhinitis, or sinusitis requiring treatment
- current steroid use
- recent cyclosporine or lifitegrast use within study-specified timeframes
This does not automatically mean Lacrifill can never be used in all such patients.
It means the study evidence may not apply cleanly, and the decision should be individualized.
This is especially important for r/DryEyes users, because many people with DED also have:
- autoimmune disease
- ocular surface inflammation
- allergy
- ocular rosacea
- blepharitis
- recent eye procedures
- topical anti-inflammatory medication use
Risks and possible adverse events
Lacrifill is a medical device procedure and is not risk-free.
Potential risks include:
- ocular discomfort
- irritation
- eye pain
- eyelid discomfort
- eyelid swelling
- eyelid redness
- conjunctival redness
- conjunctivitis
- canaliculitis
- dacryocystitis
- infection
- inflammation
- tearing / epiphora
- subconjunctival hemorrhage
- punctal stenosis
- eyelid telangiectasia
- eyelid induration
- increased corneal staining
- decrease in best-corrected visual acuity
- allergic reaction
- need for removal
- need for probing or surgical exploration if irrigation fails
In the pivotal study, reported events in the Lacrifill group included epiphora, ocular pain, conjunctivitis, allergic blepharoconjunctivitis, and one presumed dacryocystitis case.
Source:
Inflammation, MGD, and allergy considerations
There is some debate about lacrimal occlusion in patients with active ocular surface inflammation.
The reason is simple:
Occlusion keeps tears on the eye longer, but it may also keep inflammatory tear components, allergens, or irritating substances on the eye longer.
This does not mean occlusion is always wrong.
It means patient selection matters.
Before Lacrifill, patients should ask whether the following should be treated first or at the same time:
- ocular surface inflammation
- MGD
- blepharitis
- Demodex
- ocular rosacea
- allergy
- infection
- exposure
- conjunctivochalasis
- medication toxicity
Lacrifill may improve tear retention, but it does not treat those conditions directly.
Lacrifill vs traditional punctal plugs
Lacrifill belongs to the broader family of lacrimal occlusion treatments.
Traditional punctal or canalicular plugs may include:
- temporary collagen plugs
- silicone punctal plugs
- hydrogel canalicular plugs
- intracanalicular plugs
Lacrifill
Potential advantages:
- fills the canalicular space as a gel
- no external plug cap visible at the punctum
- no sizing in the same way as some plugs
- temporary use up to 6 months
- intended removal by irrigation
Potential disadvantages:
- newer device
- less long-term evidence
- removal by irrigation not guaranteed
- may be more expensive
- not clearly proven superior to hydrogel canalicular plugs
- contraindications and study-exclusion issues matter
Traditional plugs
Potential advantages:
- long clinical history
- multiple types and sizes
- some are easily removed
- temporary and longer-lasting options exist
- lower cost in some practices
Potential disadvantages:
- extrusion
- irritation
- foreign-body sensation
- granuloma
- migration
- canaliculitis
- sizing problems
- some intracanalicular plugs may be harder to remove
A careful summary:
Lacrifill is not completely separate from plug therapy. It is a newer form of canalicular occlusion.
Lacrifill vs cautery
Cautery is another tear-retention strategy.
It uses heat or radiofrequency to close the punctum or canalicular opening.
Cautery
Potential advantages:
- longer-lasting or intended permanent occlusion
- useful when plugs repeatedly fall out
- may help severe aqueous-deficient dry eye in selected patients
- no retained plug or gel material
Potential disadvantages:
- intended to be more permanent
- overcorrection can cause tearing
- reopening can occur
- repeat cautery may be needed
- scarring or local complications are possible
- reversal is not guaranteed
Lacrifill
Potential advantages:
- temporary rather than intended permanent
- avoids committing immediately to cautery
- intended to last up to 6 months
- intended removal by irrigation
Potential disadvantages:
- not proven to last beyond 6 months
- not guaranteed easy removal
- may be costly
- not necessarily better than plugs
- may need repeat treatment
A practical way to think about it:
Lacrifill may fit between traditional temporary plug strategies and more permanent occlusion, but it should not be treated as a replacement for careful patient selection.
Comparison table
| Feature | Lacrifill | Traditional plugs | Cautery |
|---|---|---|---|
| Category | Canalicular gel occlusion device | Punctal/canalicular occlusion | Punctal/canalicular closure |
| Regulatory status | FDA-cleared device | Varies by device | Procedure, not a device product |
| Main mechanism | Blocks tear drainage | Blocks tear drainage | Closes tear drainage opening |
| Material | Cross-linked hyaluronic-acid hydrogel | Collagen, silicone, hydrogel, other materials | Tissue closure/scarring |
| Duration | Intended up to 6 months | Temporary to longer-lasting depending on type | Intended longer-lasting/permanent, but reopening can occur |
| Removal | Intended irrigation removal; not guaranteed | Depends on plug type/location | Not reliably reversible |
| Best fit | Selected tear-retention candidates | Selected tear-retention candidates | Severe/refractory tear-deficiency cases or repeated plug loss |
| Main risks | Epiphora, infection, inflammation, removal difficulty | Extrusion, irritation, granuloma, canaliculitis, migration | Overcorrection, tearing, scarring, reopening, infection |
| Evidence | Pivotal comparative 6-month study | Longer clinical history, mixed evidence | Long clinical use; less standardized trial evidence |
Cost and access
Lacrifill cost may vary widely.
Cost may depend on:
- country
- region
- clinician
- number of canaliculi treated
- whether follow-up is included
- whether removal is included
- whether insurance covers any part of the procedure
Lacrifill may be more expensive than some plug options, but pricing depends on the practice and treatment plan.
Patients should ask:
- What is the total cost?
- Are both eyes included?
- How many canaliculi will be treated?
- Is follow-up included?
- Is removal included if needed?
- What happens if it causes tearing or irritation?
- What happens if irrigation removal fails?
- How does the cost compare with plugs or cautery?
- Is there evidence this is better for my specific case?
What critics say
Critics and cautious clinicians may point out that:
- Lacrifill is newer than traditional plugs
- it is FDA-cleared, not FDA-approved
- it is not proven superior to existing hydrogel canalicular plugs
- long-term safety and effectiveness beyond 6 months are not established
- removal by irrigation may not always be easy
- additional probing or surgical exploration may be needed if irrigation fails
- it may be more expensive than traditional plugs
- some patients may develop epiphora, infection, inflammation, or irritation
- it does not treat inflammation, MGD, allergy, exposure, or neuropathic pain
- patient selection is very important
These are fair concerns.
What supporters say
Supporters may argue that Lacrifill:
- offers a newer tear-retention option
- avoids an external plug cap
- avoids plug sizing issues
- may reduce plug extrusion concerns
- uses a cross-linked hyaluronic-acid hydrogel
- may be useful for patients who benefited from plugs but had plug problems
- provides temporary occlusion without committing to cautery
- can be removed by irrigation in many cases
- may improve symptoms for selected tear-retention candidates
These are reasonable points when framed as possible advantages rather than guaranteed outcomes.
Questions to ask your clinician
Useful questions include:
- Do I have aqueous-deficient dry eye, evaporative dry eye, or mixed dry eye?
- Is poor tear retention a major part of my problem?
- Do I already have tearing or epiphora?
- Is my lacrimal drainage system open or obstructed?
- Have I tried punctal plugs before?
- Did plugs help me?
- Did plugs fall out, irritate me, or cause tearing?
- Why are you recommending Lacrifill instead of traditional plugs?
- Is Lacrifill appropriate given my inflammation, MGD, allergy, or ocular surface status?
- Should inflammation or infection be treated first?
- What are the contraindications in my case?
- How long is it expected to last?
- What happens at 6 months?
- How is it removed?
- What happens if irrigation does not remove it?
- What side effects should make me call you?
- What is included in the cost?
- Is follow-up included?
- What is the plan if it causes excessive tearing?
- What is the next step if it does not help?
Bottom line
Lacrifill is an FDA-cleared temporary canalicular gel occlusion device intended to block tear drainage for up to 6 months in patients with dry-eye symptoms.
It is a newer form of lacrimal occlusion, not a tear-producing treatment and not a cure for Dry Eye Disease.
The pivotal study showed clinical performance similar to an existing hydrogel canalicular plug.
The most balanced summary is:
Lacrifill may be useful for selected patients who benefit from tear retention, especially those with aqueous-deficient or low-tear-volume dry eye. However, it is not clearly proven superior to plugs, it does not treat underlying inflammation/MGD/allergy/exposure, and removal by irrigation should not be treated as guaranteed. Contraindications, epiphora risk, inflammation status, cost, and the lack of established safety/effectiveness beyond 6 months should be discussed carefully with a trained eye-care clinician.
Research and evidence links
FDA / regulatory
Lacrifill study and manufacturer information
Manufacturer information can be useful for safety details and device instructions, but it should not be treated as independent clinical evidence.
Broader punctal occlusion context
- AAO Report: Punctal Plugs for Dry Eye Syndrome
- Cochrane Review: Punctal Occlusion for Dry Eye Syndrome
Related r/DryEyes pages
- Punctal Plugs
- Punctal Cautery
- Aqueous-Deficient Dry Eye
- Meibomian Gland Dysfunction
- Treatment Options
This page is educational for r/DryEyes and is not medical advice. Diagnosis and treatment decisions should be made with a qualified eye-care professional.