NCT04556838

Study of VVN001 Ophthalmic Solution in Dry Eye Disease

A Phase 2a, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Safety and Efficacy Activity of 1% and 5% VVN001 Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: VivaVision Biotech, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	VVN001 Ophthalmic Solution 1%	VVN001 Ophthalmic Solution 1%
DRUG	VVN001 Ophthalmic Solution 5%	VVN001 Ophthalmic Solution 5%
DRUG	Vehicle	VVN001 Ophthalmic Solution Vehicle

Timeline

• Start date: 2020-12-03
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-09-21
• Last updated: 2023-12-13
• Results posted: 2023-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study