NCT06964061Active, not recruitingPhase 1
Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
An Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Biodegradation Period of PA5346 Ocular Implant, 115mcg When Administered to Patients With Open-Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
The goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 18 Mar 2025
- Start date
- 10 Jun 2025
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- PolyActiva Pty Ltd
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT06964061
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 10 Jun 2025 to the primary completion date, 15 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
- Uncontrolled medical conditions
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cataract & Eye Surgery Centre Coordinator of this site? Confirm its status | Doncaster | Australia | Unknown status |
| Melbourne Eye Specialists Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.