NCT04060758CompletedPhase 1
Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma
An Open Label, Comparative, Sequential-dose, Multi-centre Study Involving Intracameral Administration of a PA5108 Latanoprost FA SR Ocular Implant Into the Eye of Patients With Mild-moderate Glaucoma
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
This is a multi-centre, open label, interventional, comparative, phase I study to identify a safe and efficacious dose (within the range of 14.7mcg to 35.5 mcg) of PA5108 (PolyActiva product code) Latanoprost free acid (FA) sustained release (SR) Ocular Implant in adults who have Primary Open Angle Glaucoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 5 Aug 2019
- Start date
- 11 Mar 2020
- Primary completion date
- 13 May 2025
- Lead sponsor
- PolyActiva Pty Ltd
- Diseases
- Glaucoma
- NCT number
- NCT04060758
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 37
- From 11 Mar 2020 to the primary completion date, 13 May 2025
- 9 sites in 2 countries
- 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
- Recent surgery in the study eye surgery (including laser).
- Known sensitivity to any component of the product (e.g. latanoprost or polytriazole sensitivity), or to topical therapy used during course of study (e.g. povidone iodine, or anaesthetics).
- Ocular medication in either eye of any kind within 30 days of screening.
Other illness
- Have pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
- Have a history of or current ocular inflammation.
- Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca or infection) which might interfere with the study.
- Any other clinically significant disease (as determined by physician) which might interfere with the study.
Other
- Participants who:
- Have aphakic eyes or only one eye.
- Central corneal thickness in either eye that is less than 470 µm or greater than 630 µm at screening (or a difference between the eyes \>70 µm).
- Any abnormality in either eye preventing reliable applanation tonometry, including aphakic eyes or significant corneal guttatae.
Who the study is looking for
- Participants who:
- Diagnosis of primary open angle glaucoma.
- Unmedicated 8:00am IOP ≥ 24 mmHg and ≤ 36mmHg in the intent to treat eye. Additionally, the IOP at 12:00 and 16:00 hrs must be ≥ 20mmHg and ≤ 36mmHg.
- Corrected visual acuity in each eye greater than or equal to +0.3logMAR.
- Minimum central endothelial cell density of greater than or equal to 1600 cells per mm2
- Currently managing their POAG with IOP lowering drop therapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bendigo Eye Clinic Coordinator of this site? Confirm its status | Bendigo | Australia | Unknown status |
| PersonalEYES Coordinator of this site? Confirm its status | Castle Hill | Australia | Unknown status |
| Centre for Eye Research Australia Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Essendon Eye Clinic Coordinator of this site? Confirm its status | Essendon | Australia | Unknown status |
| Melbourne Eye Specialists Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Goodwood Eye Centre Coordinator of this site? Confirm its status | Millswood | Australia | Unknown status |
| Eyes First Coordinator of this site? Confirm its status | Springvale | Australia | Unknown status |
| Eye Surgery Associates Coordinator of this site? Confirm its status | Vermont South | Australia | Unknown status |
| Capital Eye Specialists Coordinator of this site? Confirm its status | Te Aro | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.