Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

November 17, 2024 updated by: VivaVision Biotech, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Eye & ENT Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VVN001
VVN001 Ophthalmic Solution, 5%
Drug: VVN001 Ophthalmic Solution, 5%
VVN001 Ophthalmic Solution, 5%
Placebo Comparator: Vehicle
VVN001 Ophthalmic Solution, Vehicle
Drug: VVN001 Ophthalmic Solution, Vehicle
VVN001 Ophthalmic Solution, Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Fluorescein Staining
Time Frame: 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).
Day 84

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VivaVision Biotech, Inc

Investigators

  • Principal Investigator: Xinghuai Sun, Eye & ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 6, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVN001-CCS-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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