Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 3:53 AM
Study NCT ID:
NCT06964061
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
PolyActiva Pty Ltd
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: