IVW-1001 Eyelid Wipe for Dry Eye Syndrome

Overseen By Elizabeth Kaminsky, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: IVIEW Therapeutics Inc.

Disqualifiers: Glaucoma, Ocular hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of using a special eyelid wipe designed to help those with dry eye syndrome, a condition causing dryness and discomfort in the eyes. Researchers aim to determine which wiping technique best relieves symptoms. Participants will try one of three methods of using the IVW-1001 Ophthalmic Eyelid Wipe. Individuals experiencing dry eye symptoms and who have used artificial tears in the past month may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

What prior data suggests that the IVW-1001 Ophthalmic Eyelid Wipe is safe for treating dry eye syndrome?

Research shows that the IVW-1001 Eyelid Wipe is generally safe to use. Previous studies on this treatment for dry eye syndrome involved various patients and found no major safety concerns. Specifically, these studies reported no significant side effects from using the wipe.

The treatment includes a compound that targets specific receptors to relieve dry eye symptoms. Safety results from earlier trials confirm its safe use in humans. While no treatment is entirely without risk, the data so far suggests that the IVW-1001 wipe is safe for most people in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IVW-1001 Ophthalmic Eyelid Wipe because it offers a novel, hands-on approach to managing Dry Eye Syndrome. Unlike typical treatments like artificial tears or prescription eye drops, which focus on adding moisture to the eye surface, this wipe targets the eyelid area directly. It comes in three unique methods, each applying different pressures and targeting the eyelash line to help maintain tear film stability and improve eyelid hygiene. This could potentially provide relief by addressing one of the root causes of dry eye symptoms rather than just treating the symptoms themselves.

What evidence suggests that the IVW-1001 Ophthalmic Eyelid Wipe is effective for dry eye syndrome?

Research shows that IVW-1001 Ophthalmic Eyelid Wipe yields promising results for people with dry eye syndrome. In earlier studies, this treatment significantly improved both the signs and symptoms of dry eyes. Participants in this trial will use the IVW-1001 Ophthalmic Eyelid Wipe in one of three different methods to assess its effectiveness. The wipes contain a special ingredient that targets a specific part of the eye to relieve dryness. Patients experienced relief without any major safety concerns. Overall, this treatment has shown potential to effectively manage dry eye symptoms. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Dry Eye Syndrome who have a certain level of tear production and vision clarity, are not pregnant or nursing, willing to use birth control, and have used artificial tears within the last month. People with severe corneal staining, high eye pressure, or a history of glaucoma/ocular hypertension can't join.

Inclusion Criteria

Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit

BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit

I am not pregnant, not breastfeeding, and will use birth control as required.

Exclusion Criteria

Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit

IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit

I have or had glaucoma or high eye pressure that needed treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 50-day double-masked period comparing three dosing techniques using IVW-1001 Ophthalmic Eyelid Wipe

7 weeks

Washout

A 14-day washout period between treatment phases

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IVW-1001 Ophthalmic Eyelid Wipe

Trial Overview The study is testing IVW-1001 Ophthalmic Eyelid Wipe through a double-masked controlled trial comparing three different dosing techniques to see which one works best for treating Dry Eye Syndrome.

How Is the Trial Designed?

Group I: IVW-1001 Ophthalmic Wipe - Method 3 Experimental Treatment 1 Intervention

With eyes completely closed, the subject should lay the IVW-1001 Ophthalmic Eyelid Wipe on the upper eyelid for 5 seconds, especially over the lash margin covering the eyelash line, then wiping the upper eyelid in a nasal to temporal direction. while applying moderate pressure directly at the lash margin covering the eyelash line .

Group II: IVW-1001 Ophthalmic Wipe - Method 2 Experimental Treatment 1 Intervention

With eyes completely closed, the subject should wipe the upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure directly at the lash margin covering the eyelash line.

Group III: IVW-1001 Ophthalmic Wipe - Method 1 Experimental Treatment 1 Intervention

With eyes completely closed, the subject should wipe upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure to the eyelid skin slightly away from the eyelash line.

Who Is Running the Clinical Trial?

IVIEW Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

470+

Citations

1. patlynk.com patlynk.com/trial/NCT07140380

IVW-1001 Eyelid Wipe Techniques for Dry Eye Disease The study aims to assess how safe and effective different doses of the IVW-1001 Ophthalmic Eyelid Wipe are.

2. prnewswire.com prnewswire.com/news-releases/iview-therapeutics-announces-topline-results-from-phase-12-trial-of-ivw-1001-ophthalmic-eyelid-wipe-for-dry-eye-disease-302371387.html

IVIEW Therapeutics Announces Topline Results from ... The trial achieved statistically significant and clinically meaningful improvements in key signs and symptoms of dry eye patients at the final timepoint.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06400459

IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 ...

4. ophthalmologytimes.com ophthalmologytimes.com/view/iview-therapeutics-completes-enrollment-in-phase-1-2-trial-for-ophthalmic-eyelid-wipe-for-the-treatment-of-dry-eye-disease

iView Therapeutics completes enrollment in phase 1/2 trial ... IVW-1001 is a novel TRPM8 agonist delivered via ophthalmic eyelid wipe, being developed to treat DED.

5. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2799177

Nonclinical Development of a Novel Therapeutic Ophthalmic ... Conclusions : Efficacy, ocular PK and toxicity studies of IVW-1001 OEW and OS demonstrated effective and safe ocular target concentrations when applied to the ...

6. bioadvance.com bioadvance.com/first-patient-dosed-in-phase-2b-clinical-trial-of-ivw-1001-for-dry-eye-disease/

First Patient Dosed in Phase 2b Clinical Trial of IVW-1001 ... IVW-1001 eyelid wipe is an eyelid wipe saturated with the novel New Chemical Entity (NCE), a selective TRPM8 agonist, for the treatment of dry ...

7. firstwordpharma.com firstwordpharma.com/story/5934002

IVIEW Therapeutics Announces Topline Results from ... IVIEW Therapeutics Announces Topline Results from Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe for Dry Eye Disease · Safety Results Confirm ...