Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease

Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease (NCT06360133) is a Phase 3 interventional studying Dry Eye, sponsored by VivaVision Biotech, Inc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Dry Eye, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 700 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Provided written willing to sign a consent form prior to any study-related procedures. - Are between 30 and 80 years of age. - Have a history of dry eye disease in both eyes. - Have been using artificial tears within 30 days of the screening visit - Have an Eye dryness score ≥50 (0-100 point VAS) - Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min. - Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record). Who Should NOT Join This Trial: - Have a known hypersensitivity or contraindication to the IP or components of IP. - Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study. - Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Provided written informed consent prior to any study-related procedures. * Are between 30 and 80 years of age. * Have a history of dry eye disease in both eyes. * Have been using artificial tears within 30 days of the screening visit * Have an Eye dryness score ≥50 (0-100 point VAS) * Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min. * Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record). Exclusion Criteria: * Have a known hypersensitivity or contraindication to the IP or components of IP. * Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study. * Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.

Treatments Being Tested

DRUG

VVN001 Ophthalmic Solution, 5%

DRUG

VVN001 Ophthalmic Solution, Vehicle

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06360133), the sponsor (VivaVision Biotech, Inc), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06360133 clinical trial studying?

This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06360133?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06360133?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06360133. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06360133. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.