RECRUITING

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

Description

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.

Conditions

Glaucoma, Open-AngleOcular Hypertension
Talk to us

Related Conditions:

Glaucoma, Open-AngleOcular Hypertension

Study Overview

On this page

Study Details

Study overview

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.

A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension

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

Condition
Glaucoma, Open-Angle
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Eye Research Foundation, Newport Beach, California, United States, 92663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

PolyActiva Pty Ltd,

Study Record Dates

2026-11-15