Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease | NCT06360133

Studies
Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

NCT06360133

Sponsor

VivaVision Biotech, Inc

Status

Recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

700Estimated

Phase

Phase 3

Conditions

Dry Eye

Interventions

VVN001 Ophthalmic Solution, 5%
VVN001 Ophthalmic Solution, Vehicle

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Apr 6, 2024

First Submission Date that Met QC Criteria

Apr 6, 2024

First Posted Date

Apr 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VVN001	Experimental	VVN001 Ophthalmic Solution, 5%	Drug: VVN001 Ophthalmic Solution, 5%
Vehicle	Placebo Comparator	VVN001 Ophthalmic Solution, Vehicle	Drug: VVN001 Ophthalmic Solution, Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VVN001 Ophthalmic Solution, 5%	Drug	VVN001 Ophthalmic Solution, 5%	VVN001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Eye Dryness	Mean Change from baseline (Visit 2) to Day 84 (Visit 6) in the individual symptom of eye dryness (0~100 VAS scale).	Day 84

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroline Lu	Contact	86-18816562189		caroline.lu@vivavisionbio.com

Overall Officials

Name	Affiliation	Role
Xinghuai Sun	Eye & ENT Hospital of Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye & Ent Hospital of Fudan University	Recruiting	Shanghai	Shanghai Municipality		China

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases