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Clinical Trials in the USA / NCT06964191
Active, not recruiting Phase 2

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

NCT06964191 · tracked via the Priya Life Science USA tracker
Sponsor
PolyActiva Pty Ltd
Phase
Phase 2
Started
2025-05-31
Last updated
2026-07-08

Condition(s) studied

Glaucoma, Open-AngleOcular Hypertension

Investigational drug(s) / intervention(s)

PA5108 Ocular Implant low dosePA5108 Ocular Implant, high doseLatanoprost 0.005% Ophthalmic Solution

PA5108 Ocular Implant low dose: The PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use.

PA5108 Ocular Implant, high dose: The PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use.

Latanoprost 0.005% Ophthalmic Solution: Latanoprost eye drops at a concentration of 0.005%

Study summary

The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Efficacy: change in mean diurnal intraocular pressure in study eye — From Baseline to 12 weeks
  • Incidence of ocular symptoms and ocular treatment-emergent adverse events. — Day 1 to study completion until at least Week 58
    Ocular safety and tolerability (AEs)
  • Clinically significant change on slit-lamp exam — Day 1 to study completion until at least Week 58
    Slit-lamp biomicroscopy of eye to observe clinically significant changes.
  • Clinically significant change in corneal endothelial cells — Day 1 to study completion until at least Week 58
    Corneal endothelial cell density (cells/mm2) measured by specular microscopy.

Trial sites (1)

FacilityCityRegionStatus
Eye Research Foundation Newport Beach California

Other trials for the same condition

Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients. Active, not recruiting
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone) Recruiting
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes. Recruiting
AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension Active, not recruiting
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06964191 on ClinicalTrials.gov ↗ ← All trials in the USA