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

Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT06964061) is a Phase 1 interventional studying Open Angle Glaucoma (OAG) and Ocular Hypertension (OH), sponsored by PolyActiva Pty Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Open Angle Glaucoma (OAG), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 12 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Key Who May Qualify: - Ability to provide willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 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

Treatments Being Tested

COMBINATION_PRODUCT

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cataract & Eye Surgery Centre

Doncaster, Victoria, Australia

Cerulea Pty Ltd

East Melbourne, Victoria, Australia

Melbourne Eye Specialists

Melbourne, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06964061), the sponsor (PolyActiva Pty Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06964061 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06964061?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06964061?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06964061. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06964061. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.