Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07796178

Evaluation of Lacrifill

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dry Eye Cataract Surgery Dry Eye Syndromes Eye Diseases Eyes Dry Feeling of Lacrimal Apparatus Diseases Ocular Surface Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacrifill

Drug

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

Saline

Drug

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 outcomes

  1. 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

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

Secondary outcomes

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

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

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

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

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

    The Eye Dryness visual analog scale VAS will be conducted 1 month post operative with higher scores indicating more discomfort.

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

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

    The Eye Dryness visual analog scale VAS will be conducted 3 month post operative with higher scores indicating more discomfort.

Sponsors and collaborators

Lead sponsor

Eye Research Associates, LLC

Other

Registry information

Official study title

Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.