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Active Not Recruiting NCT06964061

Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions: Open Angle Glaucoma (OAG), Ocular Hypertension (OH)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 12
Sponsor: PolyActiva Pty Ltd

Location: Cataract & Eye Surgery Centre Doncaster Victoria

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06964061). StuddyBuddy aggregates publicly available trial information.