Lacrifill to Help Prevent Post-Curgery Dry Eye After Cataract Surgery
Official title: Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects
Run by Eye Research Associates, LLC · NCT07796178 · Data updated 2026-11-12
This study tests Lacrifill to see if it helps prevent dry eye symptoms after unilateral cataract surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Eye Research Associates, LLC Academic / other |
| Locations | 2 sites (Pittsburg, Kansas and 1 other locations) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07796178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older planned for bilateral cataract surgery, with corneal staining score ≥3 in the study eye and baseline OSDI ≤12.
✕Probably not a fit
Patients with recent ocular surgery within 12 months, active ocular infection or non-DED inflammation, or conditions known to alter tear film are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 study evaluates Lacrifill, in addition to saline, for preventing post-operative dry eye in adults undergoing cataract surgery. Participants must have measurable corneal staining and low pre-treatment dry eye symptoms, and they will discontinue contact lens wear during the study. The trial is conducted at sites in Kansas and Missouri and follows standard post-surgical care with an additional Lacrifill treatment. Safety and efficacy data will inform whether Lacrifill can reduce ocular surface disruption after surgery.
Why it matters
Potential benefit: If successful, Lacrifill could reduce post-operative dry eye symptoms and improve comfort and visual quality after cataract surgery.
How similar studies have gone: Previous studies in related areas have shown mixed results; this trial explores Lacrifill’s specific post-surgical prevention potential.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
Kannarr Eye Care
Pittsburg, Kansas, United States Recruiting -
Insight Eyecare Specialties Inc
Kansas City, Missouri, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.