Study of VVN001 Ophthalmic Solution in Dry Eye Disease

NCT ID: NCT04556838

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2021-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VVN001, 1%

VVN001, 1% ophthalmic solution

Group Type: EXPERIMENTAL

VVN001 Ophthalmic Solution 1%

Intervention Type: DRUG

VVN001 Ophthalmic Solution 1%

VVN001, 5%

VVN001, 5% ophthalmic solution

Group Type: EXPERIMENTAL

VVN001 Ophthalmic Solution 5%

Intervention Type: DRUG

VVN001 Ophthalmic Solution 5%

Vehicle

VVN001 Ophthalmic Solution Placebo

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

VVN001 Ophthalmic Solution Vehicle

Interventions

VVN001 Ophthalmic Solution 1%

VVN001 Ophthalmic Solution 1%

Intervention Type: DRUG

VVN001 Ophthalmic Solution 5%

VVN001 Ophthalmic Solution 5%

Intervention Type: DRUG

Vehicle

VVN001 Ophthalmic Solution Vehicle

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VivaVision Biotech, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lexitas

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 36586669 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VVN001-CS-201

Identifier Type: -

Identifier Source: org_study_id