ClinicalTrials.gg
RecruitingNCT07155057LaReCaUpdated Sep 29, 2025

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

An interventional study of Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML in Dry Eye Disease (DED), sponsored by Vance Thompson Vision. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Vance Thompson Vision · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dry Eye Disease (DED)

Browse trials for

03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be willing and able to understand and sign the 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Study Participants

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

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

Interventions

  • DeviceCross-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

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jun 2026, 9 months after the start.

Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 9 months is below that.

Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2025
First posted
Sep 4, 2025
StartActual
Sep 3, 2025
Primary completionEst.
Jun 2026
CompletionEst.
Dec 2026
Last update
Sep 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07155057
Lead sponsor
Vance Thompson Vision
Responsible party
Sponsor
First posted
Sep 4, 2025
Start date
Sep 3, 2025
Primary completion
Jun 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 29, 2025

Study contacts

Tiffany Facile
Contact
tiffany.facile@vancethompsonvision.com
605-371-7075
Kayla Karpuk, OD
principal investigator · Vance Thompson Vision Clinic Prof. LLC
Vance Thompson, MD
principal investigator · Vance Thompson Vision Clinic Prof. LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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