Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension
PolyActiva Pty Ltd
75 participants
May 31, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.
Eligibility
Inclusion Criteria6
- Ability to provide informed consent and follow study instructions
- 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 Criteria8
- 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
Interventions
The PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use.
The PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use.
Latanoprost eye drops at a concentration of 0.005%
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06964191