IVW-1001 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: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with dry eye syndrome, a condition that causes eyes to feel dry, gritty, or irritated. Researchers aim to evaluate the effectiveness of two different concentrations of an eyelid wipe, called IVW-1001 Ophthalmic Eyelid Wipe, in relieving these symptoms. The study seeks participants diagnosed with dry eye syndrome who have used artificial tears in the past month. Those who frequently experience dry eyes and have tried artificial tears may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that IVW-1001, the treatment under study, is generally well-tolerated. Previous studies found that most side effects were mild or moderate, meaning they weren't serious and could be managed. Both tested doses, 0.2% and 0.4%, demonstrated similar safety results.

Although the trials are ongoing, these early findings are encouraging. They suggest that the treatment might be safe for people with dry eye syndrome. However, monitoring for any side effects remains important, and participants should report anything unusual to the clinical staff. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about IVW-1001 Ophthalmic Eyelid Wipes for dry eye syndrome because they offer a unique delivery method compared to traditional eye drops and ointments. These wipes are designed for easy application directly to the eyelids, which may improve patient compliance and comfort. Additionally, with two concentration options, 0.2% and 0.4%, there's potential for customized treatment based on individual needs. This innovative approach targets the underlying causes of dry eye symptoms more effectively, providing hope for faster relief and better management of the condition.

What evidence suggests that IVW-1001 might be an effective treatment for Dry Eye Syndrome?

Research has shown that IVW-1001, in both 0.2% and 0.4% strengths, may help treat dry eye syndrome. This trial will evaluate the effectiveness of these two concentrations separately. Previous studies found significant improvements in the main signs and symptoms of dry eye at the final check-up. Both strengths proved effective, with the higher 0.4% concentration showing greater benefits in various areas. This treatment targets a receptor called TRPM8, which increases tear production and reduces discomfort. The consistent results suggest that IVW-1001 could potentially help people with dry eye symptoms. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Dry Eye Syndrome. Specific eligibility details are not provided, but typically participants should have a confirmed diagnosis and meet certain health standards set by the study.

Inclusion Criteria

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

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

I have been diagnosed with dry eye disease.

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 receive ophthalmic eyelid wipes with either 0.2% or 0.4% concentration of IVW-1001

1 week

1 visit (in-person)

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 0.2%
• IVW-1001 Ophthalmic Eyelid Wipe 0.4%

Trial Overview The study is testing two different strengths of IVW-1001 Ophthalmic Eyelid Wipes (0.2% and 0.4%) to see how well they work and what dose might be best. It's a double-masked trial, meaning neither the researchers nor participants know who gets which strength.

How Is the Trial Designed?

Group I: IVW-1001 0.4% Experimental Treatment 1 Intervention

Ophthalmic Eyelid Wipe

Group II: IVW-1001 0.2% Experimental Treatment 1 Intervention

Ophthalmic Eyelid wipe

Who Is Running the Clinical Trial?

IVIEW Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

470+

Citations

1. 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.

2. 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 ...

3. synapse.patsnap.com synapse.patsnap.com/article/iview-therapeutics-releases-phase-12-trial-results-for-ivw-1001-eyelid-wipe-in-dry-eye-treatment

IVIEW Therapeutics Releases Phase 1/2 Trial Results for ... The trial exhibited a dose-response relationship, with the higher dose of 0.2% yielding greater efficacy across multiple metrics. Key findings ...

4. 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 ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=9c7bbfa6-4b9f-4c03-a914-94eb9c986244

IVW-1001 / IVIEW Therap - Ophthalmology P1/2 data • Dry Eye Disease. Print ... Completes Patient Recruitment for Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe in Dry Eye Disease Patients ...

6. bioadvance.com bioadvance.com/iview-therapeutics-therapeutics-announces-topline-results/

IVIEW Therapeutics Announces Topline Results IVW-1001 was well-tolerated across all treatment groups, with the majority of adverse events (AEs) being mild or moderate in severity. Ocular ...