Health TrialsbyHealthPanel

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

ConditionsGlaucoma, Open-AngleOcular Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPolyActiva Pty Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PA5108 Ocular Implant low dose

    Combination product

    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

    Combination product

    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

    Drug

    Latanoprost eye drops at a concentration of 0.005%

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: PA5108 Ocular Implant low doseExperimental treatment 2 interventions
Group B: PA5108 Ocular Implant high doseExperimental treatment 2 interventions
Group C: Latanoprost ophthalmic solution 0.005%Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy: change in mean diurnal intraocular pressure in study eye

Time frame
From Baseline to 12 weeks
2

Incidence of ocular symptoms and ocular treatment-emergent adverse events.

Ocular safety and tolerability (AEs)

Time frame
Day 1 to study completion until at least Week 58
3

Clinically significant change on slit-lamp exam

Slit-lamp biomicroscopy of eye to observe clinically significant changes.

Time frame
Day 1 to study completion until at least Week 58
4

Clinically significant change in corneal endothelial cells

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

Time frame
Day 1 to study completion until at least Week 58

Secondary outcomes

1

Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.

Time frame
Weeks 2-52

Other outcomes

1

Exploratory: Gather data on implant administration procedure and overall experience from study participants.

A questionnaire comprising two questions will be used at Week 24 and Week 58 to assess the administration procedure.

Time frame
At 24 and 58 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PolyActiva Pty Ltd

Lead sponsor

IUVO S.r.l.

Collaborator

Source ClinicalTrials.gov
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