30 Participants NeededMy employer runs this trial

Lacrifill for Dry Eye Syndrome

PM
CB
Overseen ByCheryl Bayley
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists
Must be taking: Antihistamines, Birth control, Lifitegrast, Cyclosporine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Lacrifill can assist contact lens wearers who experience dry eyes after long periods. Researchers seek to find out if regular use of Lacrifill for 2-3 months can enhance comfort and alleviate dry eye symptoms. It suits contact lens users who have tried other dry eye treatments but still feel discomfort. As a Phase 4 trial, Lacrifill has already received FDA approval and proven effective, and this research explores its benefits for a broader range of patients.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of antihistamines, birth control medication, Lifitegrast, and cyclosporine. If you are using other eye drops, you may need to stop those, as the trial excludes people using topical eye drops other than for dry eye treatment.

What is the safety track record for Lacrifill?

A previous study found Lacrifill to be safe for patients. The FDA has approved Lacrifill, indicating it passed important safety tests. These tests demonstrated that Lacrifill effectively keeps eyes moist. Participants in these studies did not report any major side effects, suggesting it is well-tolerated by most users. For those considering joining a trial, this information can reassure about using Lacrifill.12345

Why are researchers enthusiastic about this study treatment?

Lacrifill is unique because it offers a new approach for treating Dry Eye Syndrome. Unlike traditional treatments like artificial tears and anti-inflammatory drops, which mainly provide temporary relief or focus on reducing inflammation, Lacrifill potentially targets the underlying cause by enhancing natural tear production. This could mean longer-lasting relief and improved eye health over time, which is why researchers are optimistic about its potential impact.

What is the effectiveness track record for Lacrifill in treating dry eye syndrome?

Research has shown that Lacrifill, the treatment under study in this trial, alleviates dry eye symptoms. One study reported that participants using Lacrifill experienced an average increase of 3.67 mm in their Schirmer test scores, which measure tear production, after three months. Another study found that the treatment significantly improved both the signs and symptoms of dry eye for up to six months. Additionally, 63% of users reported their eyes felt better, and 57% said their eyes felt wetter. These results suggest Lacrifill can be a helpful option for those dealing with dry eye discomfort.26789

Are You a Good Fit for This Trial?

This trial is for adults over 21 who wear contact lenses but have trouble wearing them comfortably due to dry eye, have tried other dry eye treatments, and meet certain test results related to dry eyes. Participants should be on stable doses of any allergy or birth control medications if they use them.

Inclusion Criteria

I am taking a stable dose of antihistamines, birth control, Lifitegrast, or cyclosporine.
* Schrimers Anesthetized less than or equal to 10
* CLDEQ-8 greater than or equal to 12
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use Lacrifill regularly to assess its effect on dry eye signs and symptoms over a 2-3 month period

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lacrifill

Trial Overview

The study tests Lacrifill, a treatment used regularly for 2-3 months, to see if it helps people with dry eyes wear their contact lenses longer and more comfortably. All participants receive the same treatment (no comparison group).

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LacrifillExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists

Lead Sponsor

Nordic Pharma, USA

Industry Sponsor

Trials
4
Recruited
240+

Citations

A Retrospective Crossover Study on Cross-Linked Hyaluronic ...

This study provides preliminary evidence that Lacrifill outperforms Restasis during the first two months of treatment in managing refractory DED ...

Clinical Trial and Product Data

LACRIFILL Canalicular Gel has been cleared for use by the FDA based on the results of clinical studies showing it's safe for patients and effective at keeping ...

LACRIFILL ® Canalicular Gel: A Paradigm Shift in Dry Eye ...

Out of 63 respondents, 63% reported that their eyes felt better; 57% said their eyes felt wetter; 94% stated they had had no post-implantation infections; and ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38875184/

Effectiveness and safety of a novel crosslinked hyaluronate ...

Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months. Trial registration: ...

(PDF) Cross-linked hyaluronic acid gel occlusive device for ...

Schirmer's tests demonstrated an average increase over baseline of 3.67 mm after 3 months. TBUT improved 87% and TMH increased by 57% at 3 months over baseline.

Evaluation of a preservative-free, cross-linked sodium ... - PMC

The purpose of this pilot trial was to evaluate the efficacy and benefits of a preservative-free cross-linked sodium hyaluronate solution (Lacri + ® , MP Labo, ...

KERATITIS SICCA AND DRY EYE SYNDROME

KCS is a specific disorder causing dry eyes because of a qualitative and quantitative abnormality of lacrimal gland secretions.

Dry Eye Disease (Keratoconjunctivitis Sicca)

Dry eye disease associated with SS is believed to affect 1%-2% of the population, and 90% of those affected are women. Data on race and ...

Keratoconjunctivitis Sicca in Sjögren Disease: Diagnostic ...

Keratoconjunctivitis sicca (KCS), also commonly known as dry eye disease (DED), is one of the most prevalent and crippling features of Sjögren disease (SD), ...