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

Phase 2

Completed

• Conditions: Glaucoma, Open-Angle
• Interventions: Drug: VVN539 Ophthalmic Solution 0.02%; Drug: VVN539 Ophthalmic Solution 0.04%; Drug: VVN539 Ophthalmic Solution Vehicle

• Registration Number: NCT05451329
• Lead Sponsor: VivaVision Biotech, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Study Start: 2022-07-12
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Status Verified: 2023-12
• Results First Submitted: 2023-12-20
• Results First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Results First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VVN539 Ophthalmic Solution 0.02%	VVN539 Ophthalmic Solution 0.02%	VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.04%	VVN539 Ophthalmic Solution 0.04%	VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution Vehicle	VVN539 Ophthalmic Solution Vehicle	VVN539 Ophthalmic Solution Vehicle

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure	8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21	mmHg

Secondary Outcome Measures

Name	Time	Method
Mean Change in Intraocular Pressure From Baseline	8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21	mmHg

Trial Locations

Locations (1)

Lexitas; 🇺🇸 Durham, North Carolina, United States