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NCT Number: NCT07155057

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

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

Recruiting

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, 57105, United States

Location status: Recruiting

Location contact

Kristin Dunne

CONTACT

[email protected]

Tiffany R Facile

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany Facile

CONTACT

[email protected]

605-371-7075

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Official study title

A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery

Acronym: LaReCa

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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