Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT06964061 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-04-28
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.
Conditions
- Open Angle Glaucoma (OAG)
- Ocular Hypertension (OH)
Interventions
- 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.
Sponsors & Collaborators
-
PolyActiva Pty Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-10
- Primary Completion
- 2027-02-15
- Completion
- 2027-04-15
Countries
- Australia
Study Locations
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