An Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Biodegradation Period of PA5346 Ocular Implant, 115mcg When Administered to Patients With Open-Angle Glaucoma or Ocular Hypertension

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
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.

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
Other Locations
Australia
Cataract & Eye Surgery Centre
RECRUITING
Doncaster
Melbourne Eye Specialists
RECRUITING
Melbourne
Contact Information
Primary
Vanessa Waddell
vanessa.waddell@polyactiva.com
+61 3 90203565
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 12
Treatments
Experimental: PA5436 Ocular Implant, 115mcg
PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection
Related Therapeutic Areas
Hypertension
Ocular Hypertension (OHT)
Glaucoma
Pigment-Dispersion Syndrome
Sponsors
Leads: PolyActiva Pty Ltd

This content was sourced from clinicaltrials.gov

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