Actively Recruiting
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
Led by PolyActiva Pty Ltd · Updated on 2025-06-13
75
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
Sponsors
P
PolyActiva Pty Ltd
Lead Sponsor
I
IUVO S.r.l.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 intraocular pressures across 2 visits following washout of IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity in study eye using Early Treatment Diabetic Retinopathy Study chart
- Qualifying corneal endothelial cell density in the study eye
You will not qualify if you...
- Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or peripheral anterior synechiae in the inferior angle in either eye
- Advanced or severe glaucoma
- Disqualifying central corneal thickness in either eye
- Significant other eye conditions that prevent accurate assessment of intraocular pressure and corneal health
- Uncontrolled medical conditions
- Previous injectable glaucoma medication into the anterior chamber of the study eye
- Intravitreal injections in the study eye within 3 months before screening or planned during the study
- Unwilling or unable to stop soft contact lens wear at least 2 days and hard contact lens wear at least 1 week before study visits and implant days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
Research Team
V
Vanessa Waddell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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