Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

VivaVision Biotech

Status and phase: Enrolling; Phase 3

Conditions: Dry Eye

Treatments: Drug: VVN001 Ophthalmic Solution, Vehicle; Drug: VVN001 Ophthalmic Solution, 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06360133

VVN001-CCS-301

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 2 patient groups, including a placebo group

VVN001

Experimental group

Description:

VVN001 Ophthalmic Solution, 5%

Treatment:

Drug: VVN001 Ophthalmic Solution, 5%

Vehicle

Placebo Comparator group

Description:

VVN001 Ophthalmic Solution, Vehicle

Treatment:

Drug: VVN001 Ophthalmic Solution, Vehicle