Dry Eye Disease (DED)LaReCaNCT07155057
Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery
A study testing Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML in people with Dry Eye Disease (DED), run by Vance Thompson Vision at 1 site in United States.
Trial summary
To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, 57105
Tiffany R Facile, tiffany.facile@vancethompsonvision.com
Kristin Dunne, kristin.dunne@vancethompsonvision.com
About this study
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
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.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3MLDevice
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 group | Role | What they receive |
|---|---|---|
| Study Participants | Other | Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively Receives: Device: Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start3 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayla Karpuk, OD, Principal investigator, Vance Thompson Vision Clinic Prof. LLCVance Thompson, MD, Principal investigator, Vance Thompson Vision Clinic Prof. LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155057
- Sponsor's protocol ID
- Lacrifill IIT
- Acronym
- LaReCa
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No