Double-Masked, Vehicle-Controlled, Randomized, Phase II Study of the Ocular Hypotensive Activity and Safety of VVN539 Ophthalmic Solution.

ABSTRACT:

Purpose

To assess safety and ocular hypotensive efficacy of VVN539 ophthalmic solution in a first-in-human study.

Design

Multicenter, double-masked, randomized, vehicle-controlled, dose-response, parallel-comparison study.

Participants

Sixty-eight subjects with ocular hypertension (OHT) or open-angle glaucoma enrolled at 5 private practices.

Methods

After washout of ocular hypotensive medications as required, the subjects were randomized to receive either VVN539 ophthalmic solution 0.02%, 0.04%, or vehicle once-daily (QD) in the morning (5 days), once-daily in the evening (6 days) and then twice-daily (6 days).

Main outcome measures

Comparison of VVNM539 to its vehicle in mean intraocular pressure (IOP) at each diurnal time point (8:00am, 10:00am, and 4:

SUBMITTER: Wirta D 

PROVIDER: S-EPMC10772809 | biostudies-literature | 2024 Mar-Apr

REPOSITORIES: biostudies-literature