Ocular Hypertension (OH), Open Angle Glaucoma (OAG)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTPA5436 Ocular Implant, 115mcg
The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.
Sponsors
PolyActiva Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Ability to provide informed consent and follow study instructions * 18 years of age or older * Diagnosis of open-angle glaucoma or ocular hypertension in both eyes * Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable * Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye * Qualifying corneal endothelial cell density (CEDC) in the study eye Key
Exclusion criteria
* Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye. * Advanced or severe glaucoma * Disqualifying central corneal thickness in either eye * Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health * Uncontrolled medical conditions * Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye * Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study * Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: change in mean diurnal intraocular pressure in study eye | Weeks 2, 12, 26 and 52 | — |
| Incidence of ocular symptoms and ocular treatment-emergent adverse events | Day 1 through study completion at least until Week 52 | Ocular safety and tolerability (AEs) |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points. | Weeks 2-52 |
Countries
Australia
Outcome results
None listed