RECRUITING

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

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Conditions

Glaucoma, Open-AngleOcular Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-31
Study Completion:2026-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06964191

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent and follow study instructions
  2. * 18 years of age or older
  3. * Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
  4. * Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
  5. * Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
  6. * Qualifying corneal endothelial cell density (CEDC) in the study eye
  1. * Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
  2. * Advanced or severe glaucoma
  3. * Disqualifying central corneal thickness in either eye
  4. * Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
  5. * Uncontrolled medical conditions
  6. * Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
  7. * 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
  8. * 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

Contacts and Locations

Study Contact

Vanessa Waddell
CONTACT
+61 3 9020 3565
vanessa.waddell@polyactiva.com

Study Locations (Sites)

Eye Research Foundation
Newport Beach, California, 92663
United States

Collaborators and Investigators

Sponsor: PolyActiva Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-31
Study Completion Date2026-11-15

Study Record Updates

Study Start Date2025-05-31
Study Completion Date2026-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Glaucoma, Open-Angle
  • Ocular Hypertension