33 Participants NeededMy employer runs this trial

Rinsada for Dry Eye

(RINSE-A Trial)

SS
Overseen BySrinivas S Kondapalli
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 explores a new treatment called Rinsada to determine its effectiveness in reducing inflammation that contributes to dry eye. Researchers will treat one eye with Rinsada while leaving the other eye untreated to compare the effects. Individuals who test positive for MMP-9 in both eyes, a marker linked to inflammation, may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research in dry eye treatment.

Will I have to stop taking my current medications?

If you are currently using topical anti-inflammatory medications like corticosteroids, cyclosporine, lifitegrast, or topical NSAIDs, you will need to stop them 14-30 days before joining the trial. The trial does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that Rinsada is likely to be safe for humans?

Research shows that Rinsada is generally well-tolerated. In earlier studies, researchers found no major safety issues. Specifically, over 70% of patients experienced improvements without serious side effects. The treatment works by washing the eye surface to remove irritants and debris, which helps reduce swelling.

Some evidence suggests that Rinsada remains safe even with regular use for 3 to 6 months, as users did not report serious side effects during this period. While individual experiences can vary, the data so far indicates that Rinsada is a safe option for those dealing with dry eye symptoms.12345

Why are researchers excited about this trial?

Most treatments for dry eye, like artificial tears, lubricating ointments, or anti-inflammatory drops, mainly focus on providing temporary relief or reducing inflammation. But Rinsada is unique because it targets the underlying causes of dry eye with a novel mechanism of action. Researchers are excited about Rinsada because it promises a more sustained improvement in eye moisture levels, which could mean longer-lasting relief for patients. This innovative approach could change the game for those suffering from persistent dry eye symptoms.

What evidence suggests that Rinsada might be an effective treatment for dry eye?

Research has shown that Rinsada can significantly reduce eye inflammation by lowering MMP-9, a substance linked to inflammation. This reduction can reach up to 70% shortly after treatment. Patients often experience less discomfort and clearer vision within hours of using Rinsada. In this trial, participants will receive Rinsada treatment in one eye, while the other eye serves as a control. The device thoroughly cleans the eye's surface, helping to stabilize the tear layer and potentially enhancing the effectiveness of other treatments. Overall, Rinsada presents a promising option for those with dry eye symptoms.12467

Are You a Good Fit for This Trial?

This trial is for people diagnosed with dry eye disease. Specific inclusion and exclusion criteria are not listed, but generally participants should have symptoms of dry eyes and be able to follow study procedures.

Inclusion Criteria

Both of my eyes have tested positive for MMP-9.

Exclusion Criteria

Contact lens wear within 12-24 hours prior to testing
History of hypersensitivity to saline irrigation or study materials
Any systemic inflammatory disease judged by investigators to confound tear film MMP-9 level
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ocular surface rinsing to reduce inflammation

3 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rinsada

Trial Overview

The study is testing whether rinsing parts of the eye (the inner eyelid and surrounding areas) can reduce inflammation and improve symptoms in people with dry eye disease.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment EyeExperimental Treatment1 Intervention
Group II: Control eyeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rinsada

Lead Sponsor

Citations

The efficacy of an irrigating eyelid retractor-facilitated ocular ...

At 3 hours post-rinse, there was a statistically significant reduction in MMP-9 by complete ocular irrigation facilitated by an irrigating ...

Rinsada's irrigating eyelid retractor targets ocular surface ...

the device was shown to “statistically reduce improve patient symptoms” at 3 hours post-rinse. Further, a >70% reduction in MMP-9 and over 40% ...

RINSADA® for Lasting Dry Eye Relief

Clinical studies have shown significant reductions in the inflammatory marker MMP-9. They also reported notable improvements in patient symptoms, proving its ...

Dry Eye Disease (Keratoconjunctivitis Sicca) Treatment & ...

At Day 21, noted as early in the trial, statistically significant improvement in 4 symptoms and 3 ocular signs were observed when cyclosporine 1 ...

Recalcitrant Dry Eye Disease in a 31-Year-Old Female

This report explores the management of an otherwise healthy 31-year-old Caucasian female with chronic, refractory dry eye disease (DED) ...

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rinsada.com

rinsada.com/home

Home — rinsada--irrigating lid retractor

Rinsada is the safe, natural and most thorough way to treat an irritated eye, flush away impurities and clean the entire ocular surface – even underneath ...

Keratoconjunctivitis Sicca - Eye Disorders

Keratoconjunctivitis sicca is dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea.