LacriFill Canalicular Filler for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is a single-site, prospective, randomized (2:1) controlled study of subjects aged 18-39 who are candidates for bilateral LASIK and have dry eye symptoms (OSDI ≥13). The LacriFill group (n=50) receives bilateral lower canalicular LacriFill placement within 7 days prior to surgery plus standard postoperative care; the control group (n=25) receives standard postoperative care only. The primary outcome is the change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months after bilateral LASIK.
Who Is on the Research Team?
Phillip Brunson, OD
Principal Investigator
Mann Eye Institute
Are You a Good Fit for This Trial?
This trial is for adults aged 18-39 who are planning to have LASIK surgery on both eyes and already have symptoms of dry eye. Participants must meet a certain score on a dry eye questionnaire.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- LacriFill Canalicular Filler
Trial Overview
The study compares two groups: one gets a LacriFill canalicular filler in the lower eyelids before LASIK plus standard care, while the other receives only standard postoperative care. The main goal is to see if LacriFill improves dry eye symptoms after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Standard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50).
Standard postoperative LASIK care only; no punctal plugs, LacriFill, or other canalicular occlusion before completion of the primary 3-month endpoint unless medically necessary as rescue therapy (n=25).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mann Eye Institute
Lead Sponsor
Sengi
Industry Sponsor
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