Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VVN001

VVN001 Ophthalmic Solution, 5%

Group Type EXPERIMENTAL

VVN001 Ophthalmic Solution, 5%

Intervention Type DRUG

VVN001 Ophthalmic Solution, 5%

Vehicle

VVN001 Ophthalmic Solution, Vehicle

Group Type PLACEBO_COMPARATOR

VVN001 Ophthalmic Solution, Vehicle

Intervention Type DRUG

VVN001 Ophthalmic Solution, Vehicle

Interventions

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VVN001 Ophthalmic Solution, 5%

Intervention Type DRUG

VVN001 Ophthalmic Solution, Vehicle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No