Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

NCT06360133 | Recruiting Phase 3 DMC

• 1 other identifier: VVN001-CCS-301
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Corneal Fluorescein Staining

  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 Outcomes (1)

• Eye Dryness

  Day 84

Study Arms (2)

VVN001

EXPERIMENTAL

VVN001 Ophthalmic Solution, 5%

Drug: VVN001 Ophthalmic Solution, 5%

Vehicle

PLACEBO COMPARATOR

VVN001 Ophthalmic Solution, Vehicle

Drug: VVN001 Ophthalmic Solution, Vehicle

Interventions

VVN001 Ophthalmic Solution, 5% DRUG

VVN001 Ophthalmic Solution, 5%

VVN001

VVN001 Ophthalmic Solution, Vehicle DRUG

VVN001 Ophthalmic Solution, Vehicle

Vehicle

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (1)

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Xinghuai Sun

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Lu

CONTACT

86-18816562189; caroline.lu@vivavisionbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)