A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure

NCT05451329 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VVN539-CS-201
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days, each.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure

  mmHg

  8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21

Secondary Outcomes (1)

• Mean Change in Intraocular Pressure From Baseline

  8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21

Study Arms (3)

VVN539 Ophthalmic Solution 0.02%

ACTIVE COMPARATOR

VVN539 Ophthalmic Solution 0.02%

Drug: VVN539 Ophthalmic Solution 0.02%

VVN539 Ophthalmic Solution 0.04%

ACTIVE COMPARATOR

VVN539 Ophthalmic Solution 0.04%

Drug: VVN539 Ophthalmic Solution 0.04%

VVN539 Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

VVN539 Ophthalmic Solution Vehicle

Drug: VVN539 Ophthalmic Solution Vehicle

Interventions

VVN539 Ophthalmic Solution 0.02% DRUG

Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days

VVN539 Ophthalmic Solution 0.02%

VVN539 Ophthalmic Solution 0.04% DRUG

Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days

VVN539 Ophthalmic Solution 0.04%

VVN539 Ophthalmic Solution Vehicle DRUG

Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days

VVN539 Ophthalmic Solution Vehicle

Eligibility Criteria

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

You may qualify if:

• years of age or older.
• Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are untreated, or if treated, in the opinion of the investigator are well controlled on 2 or fewer ocular hypotensive medications prior to Visit 1.
• Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2.
• Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic Retinopathy Scale in each eye (equivalent to Snellen 20/200)

You may not qualify if:

• Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the formulation or to topical anesthetics or fluorescein.
• Unmedicated IOP of \> 36 mm Hg in either eye at any time point at Visit 2.

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (1)

Lexitas

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Xiao-Yan (Joanne) Li, M.D.
• Organization: VivaVision Biotech, Inc.

joanne.li@vivavisionbio.com

(858) 692-9752

Study Officials

• Xiao-Yan Li, M.D.

  VivaVision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: Double-masked, randomized, parallel

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: July 12, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: January 17, 2024
• Results First Posted: January 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)