Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery

NCT07155057 | Recruiting FDA Device

• 1 other identifier: Lacrifill IIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 3- month visit in non-invasive tear break up time (NITBUT) in primary eyes as measured by a non-invasive, automated ocular surface analyzer.

  Tear Break-Up time. Tear breakup time (TBUT) is a clinical measurement that assesses the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to form on the cornea after a complete blink. A rapid breakup indicates tear film instability, which is a common cause of dry eye syndrome. Interpreting TBUT results: A person's TBUT score is an indicator of their tear film health. Normal: A TBUT of 10 seconds or more typically signifies a healthy and stable tear film. Marginal/Mild to Moderate Instability: A score of 5 to 9 seconds may suggest mild to moderate tear film instability. Low/Dry Eye: A score of less than 5 seconds is a strong indicator of dry eye syndrome caused by tear film dysfunction.

  3 months

Study Arms (1)

Study Participants

OTHER

Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively

Device: Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML

Interventions

Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML DEVICE

Prospective, single-site, single-arm study enrolling 60 patients who have elected advanced IOL implantation at the time of cataract surgery and have a diagnosis of dry eye disease. The study will consist of 5 study visits, over a 3-5 month time period. Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively

Study Participants

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to understand and sign the informed consent form (ICF)
• Men or non-pregnant women age 22 or older
• Clear intraocular media other than cataract
• Diagnosis of dry eye disease (OSDI score ≥ 13)
• Non-invasive Tear break up time ≤ 10 seconds in at least one eye
• Willing and able to comply with all study related visits and procedures
• In the opinion of the investigator, patients who are appropriate for advanced technology lens implants

You may not qualify if:

• History of punctal cautery
• Lacrimal anatomy (e.g., nasolacrimal duct obstruction) that per investigator suggests that the patient would not be a good candidate for lacrimal occlusion or patients for whom lacrimal occlusion would increase risk

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, 57105, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Kayla Karpuk, OD

  Vance Thompson Vision Clinic Prof. LLC

  PRINCIPAL INVESTIGATOR

• Vance Thompson, MD

  Vance Thompson Vision Clinic Prof. LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Facile

CONTACT

605-371-7075; tiffany.facile@vancethompsonvision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)