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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06360133

Enrollment

700

Registered

2024-04-11

Start date

2024-04-01

Completion date

2027-04-30

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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.

Interventions

DRUGVVN001 Ophthalmic Solution, 5%

VVN001 Ophthalmic Solution, 5%

DRUGVVN001 Ophthalmic Solution, Vehicle

VVN001 Ophthalmic Solution, Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Secondary

Measure	Time frame	Description
Eye Dryness	Day 84	Mean Change from baseline (Visit 2) to Day 84 (Visit 6) in the individual symptom of eye dryness (0\~100 VAS scale).

Countries

China

Contacts

CONTACTCaroline Lu

caroline.lu@vivavisionbio.com86-18816562189

PRINCIPAL_INVESTIGATORXinghuai Sun

Eye & ENT Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026