PA5108 Ocular Implants for Glaucoma
VW
Overseen ByVanessa Waddell
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: PolyActiva Pty Ltd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults with open-angle glaucoma or ocular hypertension in both eyes. Participants must have a certain level of corneal cells, be able to consent and follow instructions, have specific intraocular pressure after stopping other IOP medications if needed, and meet vision acuity standards.Inclusion Criteria
I have been diagnosed with open-angle glaucoma or high eye pressure in both eyes.
I can understand and agree to the study's requirements.
My eye pressure readings are stable after stopping any eye pressure medications.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive PA5108 Ocular Implant or Latanoprost eye drops, with a second implant administered at 26 weeks
58 weeks
Regular visits for monitoring and administration
Follow-up
Participants are monitored for safety and intraocular pressure control after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- PA5108 Ocular Implant
Trial Overview The study tests the effectiveness and safety of PA5108 Ocular Implant at high and low doses versus standard Latanoprost eye drops in reducing eye pressure for patients with primary open-angle glaucoma or ocular hypertension.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: PA5108 Ocular Implant low doseExperimental Treatment2 Interventions
PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
Group II: PA5108 Ocular Implant high doseExperimental Treatment2 Interventions
PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.
Group III: Latanoprost ophthalmic solution 0.005%Active Control1 Intervention
Latanoprost ophthalmic solution 0.005% once daily pm in both eyes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PolyActiva Pty Ltd
Lead Sponsor
Trials
5
Recruited
50+
IUVO S.r.l.
Industry Sponsor
Trials
1
Recruited
20+
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