Status:
COMPLETED
Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma
Lead Sponsor:
PolyActiva Pty Ltd
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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) Lat...
Detailed Description
This is a multi-centre, open label, interventional, comparative, phase Ib dose ranging study to identify a safe and efficacious dose (within the range of 14.7 to 35.5 microgram) of PA5108 Latanoprost ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participants who:
- Have pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
- Have a history of or current ocular inflammation.
- Have aphakic eyes or only one eye.
- Recent surgery in the study eye surgery (including laser).
- Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca or infection) which might interfere with the study.
- 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.
- 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.
- Any other clinically significant disease (as determined by physician) which might interfere with the study.
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04060758
Start Date
March 11 2020
End Date
May 13 2025
Last Update
November 20 2025
Active Locations (9)
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1
PersonalEYES
Castle Hill, New South Wales, Australia, 2150
2
Goodwood Eye Centre
Millswood, South Australia, Australia, 5034
3
Bendigo Eye Clinic
Bendigo, Victoria, Australia, 3550
4
Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002