Overview

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

Status:
Not yet recruiting

Trial end date:
2023-07-08

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

VivaVision Biotech, Inc

Treatments:

Ophthalmic Solutions
Pharmaceutical Solutions

Criteria

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.