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

Part of paid clinical trials in Newport Beach, California.

Sponsor
PolyActiva Pty Ltd
Study ID
NCT06964191
Phase
PHASE2
Status
Recruiting
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Conditions

  • Glaucoma, Open-Angle
  • Ocular Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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%

Study Details

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.

Key Dates

Start date
May 31, 2025
Status verified
Apr 2025
Primary completion
Nov 15, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PA5108 Ocular Implant low dose
    PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
  • Experimental: PA5108 Ocular Implant high dose
    PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
  • Active Comparator: Latanoprost ophthalmic solution 0.005%
    Latanoprost ophthalmic solution 0.005% once daily pm in both eyes.

Primary Outcome Measure

Efficacy: change in mean diurnal intraocular pressure in study eye [ Time Frame: From Baseline to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eye Research FoundationNewport BeachCalifornia92663-

Find similar trials in Newport Beach, CA

By research site
Eye Research Foundation· Newport Beach, CA

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