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Recruiting NCT06360133

Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

Phase III Interventional Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VVN001 Ophthalmic Solution, 5%, VVN001 Ophthalmic Solution, Vehicle.
Who it may be relevant to
Registry conditions: Dry Eye. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug VVN001 Ophthalmic Solution, 5%
    VVN001 Ophthalmic Solution, 5%
  • Drug VVN001 Ophthalmic Solution, Vehicle
    VVN001 Ophthalmic Solution, Vehicle

Primary outcome measures

  • Corneal Fluorescein Staining [Time frame: Day 84]
Secondary outcome measures (1)
  • Eye Dryness [Time frame: Day 84]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Eye & Ent Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT06360133 · VVN001-CCS-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗