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RECRUITING
NCT06964191
PHASE2

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

Sponsor: PolyActiva Pty Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-05-31

Completion Date

2026-11-15

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

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%

Locations (1)

Eye Research Foundation

Newport Beach, California, United States