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
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.
Description
This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension. The study will also collect information on the implant administration procedure and overall experience from study participants. The study plans to recruit approximately 75 participants. Eligible participants will be randomly selected to receive one of the following treatments: * PA5108 Ocular Implant - low dose in the study eye, and L…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 per…
Interventions
- Combination ProductPA5108 Ocular Implant low dose
The PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use.
- Combination ProductPA5108 Ocular Implant, high dose
The PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use.
- DrugLatanoprost 0.005% Ophthalmic Solution
Latanoprost eye drops at a concentration of 0.005%
Location
- Eye Research FoundationNewport Beach, California