Evaluate Efficacy, Safety, Tolerability and Biodegradatio... | NCT06964061

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2025Actual

Primary Completion Date

Feb 15, 2027Estimated

Completion Date

Apr 15, 2027Estimated

First Submitted Date

Mar 18, 2025

First Submission Date that Met QC Criteria

Apr 30, 2025

First Posted Date

May 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

This is an open-label study that will evaluate the efficacy, safety, tolerability and biodegradation of PA5346 Ocular Implant administered as a single dose at 115mcg in adults with open-angle glaucoma or ocular hypertension.

The study plans to recruit approximately 12 participants. Eligible participants will receive a single PA5346 Ocular Implant administered into the intracameral space of the study eye and followed for approximately 52 weeks at a minimum or until the implant is no longer visible in the study eye.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PA5436 Ocular Implant, 115mcg	Experimental	PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection	Combination Product: PA5436 Ocular Implant, 115mcg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PA5436 Ocular Implant, 115mcg	Combination Product	The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.	PA5436 Ocular Implant, 115mcg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: change in mean diurnal intraocular pressure in study eye		Weeks 2, 12, 26 and 52
Incidence of ocular symptoms and ocular treatment-emergent adverse events	Ocular safety and tolerability (AEs)	Day 1 through study completion at least until Week 52

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.		Weeks 2-52

Other Outcomes

Measure	Description	Time Frame
Time to complete biodegradation of the implant assessed by gonioscopy		Day 1 through study completion at least until Week 52

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cataract & Eye Surgery Centre		Doncaster	Victoria	3109	Australia
Melbourne Eye Specialists

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases