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A gel plug for tear ducts may stop post-surgery dry eye

NCT ID NCT07796178

Disease control Sponsor: Eye Research Associates, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether Lacrifill, a gel placed in the tear duct to block tear drainage, can reduce dry eye symptoms in people who have had cataract surgery. Participants receive either Lacrifill or standard saline eye drops, and researchers compare eye discomfort scores over three months. The goal is to see if the gel keeps the eye moist and prevents the dryness that often follows surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lacrifill, a gel made of crosslinked hyaluronic acid that is placed in the tear duct to keep tears on the eye
What this could lead to
If it works, Lacrifill could offer a simple, non-drug way to prevent or ease dry eye discomfort after cataract surgery.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The gel could cause irritation, infection, or the device might not stay in place.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults ≥18 years of age. * Have the potential of 20/40 visual acuity or better post-cataract surgery. * have cataract surgery scheduled for both eyes * Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye. * willing to discontinue contact lens throughout the study? * pre-treatment OSDI scores of ≤12 (asymptomatic)? Exclusion Criteria: * Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)? * History of ocular surgery within the past 12 months (excluding cataract surgery) * Anticipated complications from cataract surgery in either eye? * History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related? * Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed. * Physical meibomian gland treatment withing 1 month of enrollment? * Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study. * Currently pregnant or breast feeding

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataract surgery Dry eye Eyes dry feeling of Ocular surface disease

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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