NCT06964191

Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: PolyActiva Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.

Detailed description

This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension. The study will also collect information on the implant administration procedure and overall experience from study participants. The study plans to recruit approximately 75 participants. Eligible participants will be randomly selected to receive one of the following treatments: * PA5108 Ocular Implant - low dose in the study eye, and Latanoprost 0.005% eye drops in the other eye * PA5108 Ocular Implant - high dose in the study eye, and Latanoprost 0.005% eye drops in the other eye * Latanoprost 0.005% eye drops in both eyes (control treatment group) If allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PA5108 Ocular Implant low dose	The PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use.
COMBINATION_PRODUCT	PA5108 Ocular Implant, high dose	The PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use.
DRUG	Latanoprost 0.005% Ophthalmic Solution	Latanoprost eye drops at a concentration of 0.005%

Timeline

• Start date: 2025-05-31
• Primary completion: 2026-11-15
• Completion: 2026-11-15
• First posted: 2025-05-09
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study