The goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.
This is an open-label study that will evaluate the efficacy, safety, tolerability and biodegradation of PA5346 Ocular Implant administered as a single dose at 115mcg in adults with open-angle glaucoma or ocular hypertension. The study plans to recruit approximately 12 participants. Eligible participants will receive a single PA5346 Ocular Implant administered into the intracameral space of the study eye and followed for approximately 52 weeks at a minimum or until the implant is no longer visible in the study eye.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.
Cataract & Eye Surgery Centre
Doncaster, Victoria, Australia
RECRUITINGCerulea Pty Ltd
East Melbourne, Victoria, Australia
RECRUITINGMelbourne Eye Specialists
Melbourne, Victoria, Australia
RECRUITINGEfficacy: change in mean diurnal intraocular pressure in study eye
Time frame: Weeks 2, 12, 26 and 52
Incidence of ocular symptoms and ocular treatment-emergent adverse events
Ocular safety and tolerability (AEs)
Time frame: Day 1 through study completion at least until Week 52
Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.
Time frame: Weeks 2-52
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