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

Launched by POLYACTIVA PTY LTD · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called PA5108 Ocular Implant for patients with open-angle glaucoma or ocular hypertension. The main goal is to find out how effective and safe this implant is in lowering eye pressure compared to the usual treatments. The study is currently not recruiting participants, but it will involve adults aged 18 and older who have been diagnosed with these eye conditions in both eyes. To be eligible, participants must be able to understand the study and follow its instructions, and they should meet certain eye health criteria.

If you join this study, you will receive the PA5108 Ocular Implant and be monitored closely for its effectiveness and safety. However, some people may not qualify due to specific eye conditions or other health issues, like advanced glaucoma or significant problems with eye pressure measurements. It's also important to note that participants will need to stop wearing certain types of contact lenses before their scheduled visits. This trial aims to improve how we manage glaucoma and ocular hypertension, which can help protect vision in the long run.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 Criteria:
• • 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