60 Participants Needed

Cross-Linked Hyaluronate Gel for Dry Eye Syndrome

(LaReCa Trial)

TF
Overseen ByTiffany Facile
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vance Thompson Vision
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special gel treatment for individuals with dry eye syndrome. The gel, called Cross-Linked Hyaluronate Gel, is applied to the tear ducts before cataract surgery to determine if it helps maintain eye moisture. Those diagnosed with dry eye disease who experience short-lasting tears may be suitable candidates. Participants should also be considering advanced lens implants as part of their cataract procedure. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for dry eye syndrome.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this gel is safe for use in cataract surgery patients?

Research has shown that cross-linked hyaluronate gel is safe for treating dry eye syndrome. Studies have found no serious side effects from hyaluronic acid, a main ingredient in the gel. Previous research demonstrated that this treatment is well-tolerated and effective, providing relief from dry eyes for at least three months. This makes it a promising option for managing dry eye symptoms safely.12345

Why are researchers excited about this trial?

Unlike the standard treatments for dry eye syndrome, which often include artificial tears or anti-inflammatory drugs, cross-linked hyaluronate gel offers a unique approach by providing sustained ocular hydration. This treatment uses a cross-linked form of hyaluronate, a naturally occurring substance in the eye, to create a gel that can be applied directly to the tear ducts. This method not only prolongs the moisturizing effects but also minimizes the need for frequent applications. Researchers are excited because this could lead to a more convenient and potentially more effective solution for those suffering from dry eyes.

What evidence suggests that this cross-linked hyaluronate gel is effective for dry eye syndrome?

Research has shown that a special gel called cross-linked hyaluronate effectively treats dry eye syndrome. Studies have found that it greatly improves eye health by reducing redness, irritation, and discharge. In this trial, participants will receive bilateral lacrimal occlusion with cross-linked hyaluronate canalicular gel. The gel keeps the eye surface moist and protected, helping to lessen inflammation and dryness. It also provides benefits that last for at least three months. Overall, this method safely and effectively relieves dry eye symptoms.24678

Who Is on the Research Team?

KK

Kayla Karpuk, OD

Principal Investigator

Vance Thompson Vision Clinic Prof. LLC

VT

Vance Thompson, MD

Principal Investigator

Vance Thompson Vision Clinic Prof. LLC

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with dry eye disease confirmed by an OSDI score of 13 or higher. Participants must be able to sign a consent form, have clear vision except for cataracts, and show tear instability. They should be willing to follow the study's procedures and visits, and suitable for advanced lens implants as per the investigator.

Inclusion Criteria

I am a man or a non-pregnant woman aged 22 or older.
My tear film breaks up in 10 seconds or less in one eye.
I am willing and able to sign the informed consent form.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Patients receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel before cataract surgery

1 week
1 visit (in-person)

Post-operative Follow-up

Participants are monitored for changes in tear break-up time and overall eye health

3 months
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cross-Linked Hyaluronate Gel
Trial Overview The trial is evaluating patient experiences with a crosslinked hyaluronate gel used before cataract surgery. This gel comes in a prefilled syringe and aims to manage symptoms of Dry Eye Syndrome during the surgical process.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vance Thompson Vision

Lead Sponsor

Trials
11
Recruited
300+

Citations

Efficacy of a Crosslinked Hyaluronic Acid-Based Hydrogel as ...The xCMHA-S was found to significantly improve ocular surface health (conjunctival hyperaemia, ocular irritation, and ocular discharge) to a greater degree than ...
Hyaluronic acid in the treatment of dry eye disease - PMCNo major complications or adverse events were reported. Artificial tears containing 0.1% to 0.4% HA were effective at improving both signs and ...
Effectiveness evaluation of hyaluronic acid-based ...Concretely, DED treatment effectiveness of eye drops was evaluated in terms of immediate hydration, protection against corneal dehydration, anti-inflammatory, ...
Cross-linked hyaluronic acid gel occlusive device for the ...The xlHA Occlusive Device offers a new, safe, and effective method to treat dry eyes. It appears to have efficacy for at least 3 months on clinical examination.
Efficacy of a Crosslinked Hyaluronic Acid-Based Hydrogel ...The xCMHA-S was found to significantly improve ocular surface health (conjunctival hyperaemia, ocular irritation, and ocular discharge) to a greater degree ...
A Post-market Study to Evaluate the Effects of Sodium ...Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression.
cross-link gel tearsINDICATIONS. LUXYAL CROSS-LINK GEL TEARS provides long and lasting relief of dry eye syndrome and ocular disorders in general, dry keratitis, xerophthalmia, ...
The Effectiveness and Safety of a Novel Crosslinked ...Conclusions Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant ...
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