Recruiting

Lacrfill

Sponsor:

Eye Research Associates, LLC

Code:

NCT07796178

Conditions

Dry Eye

Ocular Surface Disease

Cataract Surgery

Eyes Dry Feeling of

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lacrifill

Saline

Study Details

Brief 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.

Conditions

Dry Eye

Ocular Surface Disease

Cataract Surgery

Eyes Dry Feeling of

Study ID

NCT07796178

Start date

Sep 2, 2026

Status verified date

Sep, 2026

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lacrifill

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

active comparator: Saline/Standard of care

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

Interventions

Lacrifill

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

Saline

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.

Primary outcome measure

  • OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale) [ Time Frame: 1-month post operative compared to pre-treatment ]

Central Contacts and Locations

Locations

Kannarr Eye Care

Recruiting

Pittsburg, Kansas, United States, 66762

Contacts

Shane Kannarr, OD

620-232-3277skannarr@kannarreyecare.com

Principal Investigator:

Shane Kannarr, OD

Insight Eyecare Specialties Inc

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Crystal Remington, OD

816-531-9100drremington@vseyecare.com

Principal Investigator:

Crystal Remington, OD

More Information

Sponsor

Eye Research Associates, LLC

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Eye Research Associates, LLC on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.