Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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) Latanoprost free acid (FA) sustained release (SR) Ocular Implant in adults who have Primary Open Angle Glaucoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PolyActiva Pty Ltd
• Treatments: Latanoprost

Criteria

Inclusion Criteria:

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 Criteria:

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.