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NCT06964191

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
PolyActiva Pty Ltd
~75 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:PA5108 Ocular Implant low dosePA5108 Ocular Implant, high doseLatanoprost 0.005% Ophthalmic Solution

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy: change in mean diurnal intraocular pressure in study eye
Measured over From Baseline to 12 weeks
+3 more outcomes measured

Conditions

Glaucoma, Open-Angle
Ocular Hypertension

Explore related trials

Ocular HypertensionOpen Angle Glaucoma

Where it's being run

1 sites across 1 states
California1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Efficacy: change in mean diurnal intraocular pressure in study eyeFrom 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 examDay 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 cellsDay 1 to study completion until at least Week 58

    Corneal endothelial cell density (cells/mm2) measured by specular microscopy.