An Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Biodegradation Period of PA5346 Ocular Implant, 115mcg When Administered to Patients With Open-Angle Glaucoma or Ocular Hypertension
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- PolyActiva Pty Ltd
- Enrollment
- 12
- Locations
- 4
- Primary Endpoint
- Efficacy: change in mean diurnal intraocular pressure in study eye
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
PA5436 Ocular Implant, 115mcg
PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection
Intervention: PA5436 Ocular Implant, 115mcg (Combination Product)
Outcomes
Primary Outcomes
Efficacy: 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
Time Frame: Day 1 through study completion at least until Week 52
Ocular safety and tolerability (AEs)
Secondary Outcomes
- Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.(Weeks 2-52)