RecruitingPhase 2NCT06964191

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


Sponsor

PolyActiva Pty Ltd

Enrollment

75 participants

Start Date

May 31, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new eye implant called PA5108 that slowly releases medication to lower eye pressure in people with glaucoma or high eye pressure, aiming for a longer-lasting solution than daily eye drops. **You may be eligible if...** - You are 18 or older - You have open-angle glaucoma or high eye pressure (ocular hypertension) in both eyes - Your eye pressure is within a qualifying range after stopping current eye pressure medications - You have adequate vision and corneal cell health - You can follow study instructions **You may NOT be eligible if...** - You have had recent eye surgery or injury - You have other significant eye conditions affecting the study eye - You cannot safely stop current eye pressure-lowering medications 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_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%


Locations(1)

Eye Research Foundation

Newport Beach, California, United States

View Full Details on ClinicalTrials.gov

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NCT06964191


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