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Study of VVN001 Ophthalmic Solution in Dry Eye Disease

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

VVN001 Ophthalmic Solution 1%

VVN001 Ophthalmic Solution 5%

Vehicle

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide written informed consent prior to any study-related procedures .
Are 18 years of age or older.
Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
Have a history of dry eye disease in both eyes
Are currently using artificial tears and have been using within 30 days of the screening visit.
Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (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:
Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)
Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.

Exclusion Criteria:

Have a known hypersensitivity or contraindication to the IP or components of IP.
Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.
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.

Sites / Locations

Lexitas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

VVN001, 1%

VVN001, 5%

Vehicle

Arm Description

VVN001, 1% ophthalmic solution

VVN001, 5% ophthalmic solution

VVN001 Ophthalmic Solution Placebo

Outcomes

Primary Outcome Measures

Inferior Corneal Fluorescein Staining

Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.

Secondary Outcome Measures

Total Corneal Fluorescein Staining

Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20.

Regional Corneal Fluorescein Staining

Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.

Eye Dryness

Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100..

Full Information

NCT ID

NCT04556838

First Posted

September 14, 2020

Last Updated

February 25, 2023

Sponsor

VivaVision Biotech, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04556838

Brief Title

Study of VVN001 Ophthalmic Solution in Dry Eye Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

December 3, 2020 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VivaVision Biotech, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double-masked parallel

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-masked

Allocation

Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VVN001, 1%

Arm Type

Experimental

Arm Description

VVN001, 1% ophthalmic solution

Arm Title

VVN001, 5%

Arm Type

Experimental

Arm Description

VVN001, 5% ophthalmic solution

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

VVN001 Ophthalmic Solution Placebo

Intervention Type

Drug

Intervention Name(s)

VVN001 Ophthalmic Solution 1%

Intervention Description

VVN001 Ophthalmic Solution 1%

Intervention Type

Drug

Intervention Name(s)

VVN001 Ophthalmic Solution 5%

Intervention Description

VVN001 Ophthalmic Solution 5%

Intervention Type

Drug

Intervention Name(s)

Vehicle

Intervention Description

VVN001 Ophthalmic Solution Vehicle

Primary Outcome Measure Information:

Title

Inferior Corneal Fluorescein Staining

Description

Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.

Time Frame

Day 84

Secondary Outcome Measure Information:

Title

Total Corneal Fluorescein Staining

Description

Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20.

Time Frame

Day 84

Title

Regional Corneal Fluorescein Staining

Description

Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.

Time Frame

Day 84

Title

Eye Dryness

Description

Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100..

Time Frame

Day 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide written informed consent prior to any study-related procedures . Are 18 years of age or older. Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study. Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit. Have a history of dry eye disease in both eyes Are currently using artificial tears and have been using within 30 days of the screening visit. Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (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: Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments) Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min. Exclusion Criteria: Have a known hypersensitivity or contraindication to the IP or components of IP. Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye. 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.

Facility Information:

Facility Name

Lexitas

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27703

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of VVN001 Ophthalmic Solution in Dry Eye Disease

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