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Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: PolyActiva Pty Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-06-10
Completion Date
2026-11-15
Last Updated
2025-12-18
Healthy Volunteers
No
Interventions
PA5436 Ocular Implant, 115mcg
The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.
Locations (3)
Cataract & Eye Surgery Centre
Doncaster, Victoria, Australia
Cerulea Pty Ltd
East Melbourne, Victoria, Australia
Melbourne Eye Specialists
Melbourne, Victoria, Australia