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Recruiting Phase 3

Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

NCT06360133 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-04-01
Last updated
2026-08-20

Condition(s) studied

Dry Eye

Investigational drug(s) / intervention(s)

VVN001 Ophthalmic Solution, 5%VVN001 Ophthalmic Solution, Vehicle

VVN001 Ophthalmic Solution, 5%: VVN001 Ophthalmic Solution, 5%

VVN001 Ophthalmic Solution, Vehicle: VVN001 Ophthalmic Solution, Vehicle

Study 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

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Corneal Fluorescein Staining — Day 84
    Mean Change from baseline (Visit 2) to Day84 (Visit 6) in total corneal fluorescein staining (tCFS) using modified NEI/Industry Workshop (0-4 scale, using 0.5 unit increments).

Trial sites (1)

FacilityCityRegionStatus
Eye & Ent Hospital of Fudan University Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06360133 on ClinicalTrials.gov ↗ ← All trials in China