NCT06360133 Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease
| NCT ID | NCT06360133 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VivaVision Biotech, Inc |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 700 participants in total. It began in 2024-04-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Xinghuai Sun
PRINCIPAL INVESTIGATOR
Eye & ENT Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06360133 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06360133 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 700 participants.
Is NCT06360133 currently recruiting?
Yes, NCT06360133 is actively recruiting participants. Contact the research team at caroline.lu@vivavisionbio.com for enrollment information.
Where is the NCT06360133 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06360133 clinical trial?
NCT06360133 is sponsored by VivaVision Biotech, Inc. The principal investigator is Xinghuai Sun at Eye & ENT Hospital of Fudan University. The trial plans to enroll 700 participants.