NCT06964061

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: PolyActiva Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma (OAG)
• Ocular Hypertension (OH)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-10
• Primary completion: 2026-11-15
• Completion: 2026-11-15
• First posted: 2025-05-09
• Last updated: 2025-12-18

Locations

3 sites across 1 country: Australia