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Could a tiny eye implant replace daily drops for glaucoma?

NCT ID NCT06964061

Disease control Sponsor: PolyActiva Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This early-stage trial is testing a single biodegradable implant placed in the eye to lower pressure in people with open-angle glaucoma or ocular hypertension. The implant slowly releases medication over time and then dissolves. The study includes 12 adults and focuses on safety, how well it works, and how long it takes to break down.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PA5346 ocular implant (a biodegradable device that releases medication to lower eye pressure)
What this could lead to
If it works, this could lead to a new treatment option that lowers eye pressure for months with a single implant, reducing the need for daily eye drops.
What could go wrong
This is a very early (Phase 1) trial with only 12 people, so it is too small to prove effectiveness. The implant may not work as hoped or could cause side effects like eye irritation or vision changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ocular hypertension open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular hypertension (OH) Open-angle glaucoma (OAG)

Contacts and locations

Locations

  • Cataract & Eye Surgery Centre

    Doncaster, Victoria, 3109, Australia

  • Melbourne Eye Specialists

    Melbourne, Victoria, 3000, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.