ClinicalTrials.gg
RecruitingNCT07796178Updated Sep 25, 2026

Evaluation of Lacrifill

A Phase 4 interventional study of Lacrifill and Saline in Dry Eye, Ocular Surface Disease and Cataract Surgery, sponsored by Eye Research Associates, LLC. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Eye Research Associates, LLC · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Sep 25, 2026Now RecruitingFirst site in United States+2 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 542 studies in Dry Eye Syndromes with a site in United States — 51 open to participants now, 61 under way, 3 of them phase 3. Dry Eye Syndromes · United States.

Planned enrollment
308th of 472
40 · median 60
Started
2026
with 33 others
Phase 4
116 of 542
21 open now
Primary completion
2026-12
later than 25 of 60 live
Registered
534th of 542
by date

Among the 542 studies in Dry Eye Syndromes with a site in United States, this one is the 308th largest by planned enrollment of the 472 interventional ones that give a count, is one of 34 that started in 2026, is one of 116 in phase 4, reaches primary completion later than 25 of the 60 other live ones, and was the 534th registered.

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

Browse Dry Eye Syndromes studies →

Open to participants now

51 of the 542 studies in Dry Eye Syndromes with a site in United States are open now. Recruiting first, the newest first:

45 more — sign in →

All 51 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 542 studies in Dry Eye Syndromes with a site in United States, or all of them as a file.
02

Study summary

Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.

03

Conditions studied

  • Dry Eye
  • Ocular Surface Disease
  • Cataract Surgery
  • Eyes Dry Feeling of

Browse trials for

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Lacrifill

    Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions

    Drug: Lacrifill

  • Active comparator
    Saline/Standard of care

    Qualifying subjects will be treated with saline via the manufacturer's instructions

    Drug: Saline

Interventions

  • DrugLacrifill

    Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage

  • DrugSaline

    Participants will be provided with a saline eye drop which is standard of care for those recovering from cataract surgery, and other complications that could cause symptoms related to Dry Eye Disease.

06

What researchers measure

Primary outcomes

  1. OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)

    Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.

    Time frame: 1-month post operative compared to pre-treatment

Secondary outcomes

  1. • OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).

    Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.

    Time frame: pre-treatment as compared to 3 months post operative.

  2. Eye Dryness visual analog scale (VAS) Scores 1 month post operative

    The Eye Dryness visual analog scale VAS will be conducted 1 month post operative with higher scores indicating more discomfort. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.

    Time frame: 1 month post operative as compared to pre-treatment.

  3. Eye Dryness visual analog scale (VAS) Scores 3 month post operative

    The Eye Dryness visual analog scale VAS will be conducted 3 month post operative with higher scores indicating more discomfort. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.

    Time frame: 3 month post operative as compared to pre-treatment.

07

Study locations

2 of 2 sites recruiting
  • Kannarr Eye Care
    Pittsburg, Kansas 66762, United States
    Recruiting
  • Insight Eyecare Specialties Inc
    Kansas City, Missouri 64111, United States
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.

Of 84 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 3 months is below that.

Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Sep 25, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 1, 2026
StartActual
Sep 2, 2026was Aug 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Feb 15, 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
2 sites added — first site in United States
Show 2 added (2 United States)
  • Kannarr Eye Care · Pittsburg, United States
  • Insight Eyecare Specialties Inc · Kansas City, United States
Sep 25, 2026
Start date
Aug 31, 2026→Sep 2, 2026 (actual)
Sep 25, 2026
Secondary outcomes
2 description edited
What changed in the outcomes
  • DescriptionEye Dryness visual analog scale (VAS) Scores 1 month post operative: how it is measured was reworded
  • DescriptionEye Dryness visual analog scale (VAS) Scores 3 month post operative: how it is measured was reworded
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    2 sites added — first site in United States
    Show 2 added (2 United States)
    • Kannarr Eye Care · Pittsburg, United States
    • Insight Eyecare Specialties Inc · Kansas City, United States
    Start date Aug 31, 2026→Sep 2, 2026 (now actual)
    Secondary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionEye Dryness visual analog scale (VAS) Scores 1 month post operative: how it is measured was reworded
    • DescriptionEye Dryness visual analog scale (VAS) Scores 3 month post operative: how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07796178
Lead sponsor
Eye Research Associates, LLC
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Sep 2, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Sep 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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