Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

Phase 3

Recruiting

• Conditions: Dry Eye
• Interventions: Drug: VVN001 Ophthalmic Solution, Vehicle; Drug: VVN001 Ophthalmic Solution, 5%

• Registration Number: NCT06360133
• Lead Sponsor: VivaVision Biotech, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-04-06
• Study First Submitted QC: 2024-04-06
• Study First Posted: 2024-04-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	VVN001 Ophthalmic Solution, Vehicle	VVN001 Ophthalmic Solution, Vehicle
VVN001	VVN001 Ophthalmic Solution, 5%	VVN001 Ophthalmic Solution, 5%

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Eye & Ent Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China