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

A Phase 2, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of VVN539 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Drug: VVN539 Ophthalmic Solution 0.02%; Drug: VVN539 Ophthalmic Solution 0.04%; Drug: VVN539 Ophthalmic Solution Vehicle

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matt Howell, B.A.; Phone Number: 919.287.3993; Email: matt.howell@lexitas.com
• Study Contact Backup: Name: Osama Shafiq, B.S.; Phone Number: 919.287.3993; Email: osama.shafiq@lexitas.com

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Lexitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VVN539 Ophthalmic Solution 0.02%	Drug: VVN539 Ophthalmic Solution 0.02%; 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
Active Comparator: VVN539 Ophthalmic Solution 0.04%	Drug: VVN539 Ophthalmic Solution 0.04%; 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
Placebo Comparator: VVN539 Ophthalmic Solution Vehicle	Drug: VVN539 Ophthalmic Solution Vehicle; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure	mmHg	8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Intraocular Pressure From Baseline	mmHg	8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21

Collaborators and Investigators

• Sponsor: VivaVision Biotech, Inc
• Investigators: Study Director: Xiao-Yan Li, M.D., VivaVision

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: VVN539-CS-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No