NCT07796178 · Eye Research Associates, LLC
Evaluation of Lacrifill
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Lacrifill
Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage
DRUG
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pittsburg, Kansas
- Kansas City, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations