Status:
RECRUITING
Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
PolyActiva Pty Ltd
Conditions:
Open Angle Glaucoma (OAG)
Ocular Hypertension (OH)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 glauc...
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...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
- Advanced or severe glaucoma
- Disqualifying central corneal thickness in either eye
- Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
- Uncontrolled medical conditions
- Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
- Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study
- Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06964061
Start Date
June 10 2025
End Date
November 15 2026
Last Update
December 18 2025
Active Locations (3)
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1
Cataract & Eye Surgery Centre
Doncaster, Victoria, Australia, 3109
2
Cerulea Pty Ltd
East Melbourne, Victoria, Australia, 3002
3
Melbourne Eye Specialists
Melbourne, Victoria, Australia, 3000