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
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Eye Research Foundation
RECRUITING
Newport Beach
Contact Information
Primary
Vanessa Waddell
vanessa.waddell@polyactiva.com
+61 3 9020 3565
Time Frame
Start Date: 2025-05-31
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 75
Treatments
Experimental: PA5108 Ocular Implant low dose
PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
Experimental: PA5108 Ocular Implant high dose
PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
Active_comparator: Latanoprost ophthalmic solution 0.005%
Latanoprost ophthalmic solution 0.005% once daily pm in both eyes.
Related Therapeutic Areas
Sponsors
Collaborators: IUVO S.r.l.
Leads: PolyActiva Pty Ltd