LacriFill Canalicular Occlusion for Dry Eye After LASIK

Impact of LacriFill Lacrimal Occlusion on Post-LASIK Dry Eye Symptoms, Ocular Surface Recovery, and Patient-Reported Visual Quality

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: LacriFill Canalicular Filler

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Hamann Wright, Study Staff; Phone Number: 2389 713-580-2500; Email: Melissa.Wright@manneye.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Mann Eye Institute
      • Contact: Melissa Hamann Wright; Phone Number: 2389 713-580-2500; Email: Melissa.Wright@manneye.com
      • Principal Investigator: Phillip Brunson, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Age 18-39 years. Bilateral LASIK candidate. OSDI ≥13. BCDVA 20/20 or better. Discontinue soft contact lenses within 5 days of surgery and RGP lenses 4 weeks prior.

Able to complete study visits.

Exclusion Criteria:

Previous ocular surgery. Keratoconus or ectasia. Autoimmune disease. Pregnancy. Uncontrolled diabetes. Significant ocular surface disease unrelated to LASIK. Active ocular infection or inflammation.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LacriFill Group; Standard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50).	Device: LacriFill Canalicular Filler; LacriFill, a crosslinked hyaluronic acid-based bioresorbable gel, instilled for bilateral lower canalicular occlusion within 7 days prior to LASIK surgery.
No Intervention: Control Group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Ocular Surface Disease Index (OSDI) score	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Ocular Surface Disease Index (OSDI) score	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.	12 weeks
Proportion of subjects achieving ≥10-point improvement in OSDI score	Proportion of subjects achieving an improvement of 10 points or more in OSDI score from baseline following bilateral LASIK.	12 weeks
Proportion of subjects achieving OSDI score <13	Proportion of subjects with an OSDI score below 13 (normal range) at the 12-week postoperative visit.	12 weeks
Change from baseline in tear break-up time (TBUT)		12 weeks
Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)		12 weeks
Uncorrected distance visual acuity (UDVA)		12 weeks
Corrected distance visual acuity (CDVA)		12 weeks
Manifest refraction		12 weeks
Artificial tear usage and time to discontinuation of routine artificial tears	Artificial tear usage, time to discontinuation of routine artificial tears, and requirement for rescue dry eye therapy through the 12-week postoperative visit.	12 weeks
Requirement for rescue dry eye therapy	Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROWL-SS Questionnaire	PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).	12 weeks
Change from baseline in iTrace Corneal Performance Index (CPI)	Objective optical quality measure assessed at baseline and12-week postoperative visit.	12 weeks

Collaborators and Investigators

• Sponsor: Mann Eye Institute
• Collaborators: Sengi
• Investigators: Principal Investigator: Phillip Brunson, OD, Mann Eye Institute

Study record dates

Study Major Dates

• Study Start (Estimated): December 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 27, 2026
• First Submitted That Met QC Criteria: October 27, 2026
• First Posted (Actual): November 3, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: October 27, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: PB-26-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes