Study of VVN001 Ophthalmic Solution in Dry Eye Disease

NCT04556838 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VVN001-CS-201
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 84

Secondary Outcomes (3)

• Total Corneal Fluorescein Staining

  Day 84

• Regional Corneal Fluorescein Staining

  Day 84

• Eye Dryness

  Day 84

Study Arms (3)

VVN001, 1%

EXPERIMENTAL

VVN001, 1% ophthalmic solution

Drug: VVN001 Ophthalmic Solution 1%

VVN001, 5%

EXPERIMENTAL

VVN001, 5% ophthalmic solution

Drug: VVN001 Ophthalmic Solution 5%

Vehicle

PLACEBO COMPARATOR

VVN001 Ophthalmic Solution Placebo

Drug: Vehicle

Interventions

VVN001 Ophthalmic Solution 1% DRUG

VVN001 Ophthalmic Solution 1%

VVN001, 1%

VVN001 Ophthalmic Solution 5% DRUG

VVN001 Ophthalmic Solution 5%

VVN001, 5%

Vehicle DRUG

VVN001 Ophthalmic Solution Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (1)

Lexitas

Durham, North Carolina, 27703, United States

Location

Related Publications (1)

• Tauber J, Evans D, Segal B, Li XY, Shen W, Lu C, Novack GD; VVN001-CS201 Study Group. A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease. Ocul Surf. 2023 Apr;28:18-24. doi: 10.1016/j.jtos.2022.12.007. Epub 2022 Dec 29.

  PMID: 36586669 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Joanne Li, M.D.
• Organization: VivaVision Biotech, Inc.

joanne.li@vivavisionbio.com

86-02158598290

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked parallel

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: December 3, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 13, 2023
• Results First Posted: February 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)