Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular 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
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
Treatments tested in this trial
- PA5108 Ocular Implant low dose
- PA5108 Ocular Implant, high dose
- Latanoprost 0.005% Ophthalmic Solution
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
PolyActiva Pty Ltd
Lead sponsor
IUVO S.r.l.
Collaborator
Source ClinicalTrials.gov