Recruiting

Hyaluronate Gel

Sponsor:

Vance Thompson Vision

Code:

NCT07155057

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief summary:

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

Conditions

Dry Eye Disease (DED)

Study ID

NCT07155057

Start date

Sep 3, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Study Participants

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

Interventions

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

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

Primary outcome measure

  • 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. [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Tiffany Facile

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

Locations

Vance Thompson Vision Clinic, Prof. LLC

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Tiffany R Facile

tiffany.facile@vancethompsonvision.com

Kristin Dunne

kristin.dunne@vancethompsonvision.com

More Information

Sponsor

Vance Thompson Vision

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vance Thompson Vision on 2025-09-29.