RecruitingPhase 1NCT06964061

Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension

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


Sponsor

PolyActiva Pty Ltd

Enrollment

12 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new tiny implant placed in the eye (called PA5346) to lower eye pressure in people with glaucoma or high eye pressure, as an alternative to daily eye drops. **You may be eligible if...** - You are 18 or older - You have been diagnosed with open-angle glaucoma or high eye pressure (ocular hypertension) in both eyes - Your eye pressure falls within a qualifying range after stopping any current eye pressure medications - You have adequate vision and eye cell health (corneal endothelial cell density) - You are able to understand and follow study instructions **You may NOT be eligible if...** - You have had recent eye surgery - You have certain other eye conditions that could affect the results - You are on medications that cannot be stopped for the washout period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(3)

Cataract & Eye Surgery Centre

Doncaster, Victoria, Australia

Cerulea Pty Ltd

East Melbourne, Victoria, Australia

Melbourne Eye Specialists

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06964061