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