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Recruiting NCT07155057

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

No phase Interventional Dry Eye Disease (DED)

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED). Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

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.

Interventions

  • Device 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 measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Vance Thompson Vision Clinic, Prof. LLC — Sioux Falls

Identifiers

NCT: NCT07155057 · Lacrifill IIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗