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

NCT04060758 | Completed Phase 1 DMC

• 1 other identifier: LATA CS102
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 9

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

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• Effective dose

  Determine the minimum effective dose (as daily release rate of LtpFA) that achieves an IOP lowering effect \>20% with minimal adverse events.

  Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26.

• Safety and Tolerability-incidence of treatment emergent Adverse Events

  Assess the safety and tolerability of PA5108 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (Primary). Incidence of Treatment-Emergent Adverse Events from visit 1 until end of study. Safety laboratory evaluations (biochemistry, haematology, urinalysis). Physical examinations and vital signs. Changes in ocular examinations from baseline to end of study.

  Incidence of Treatment-Emergent Adverse Events throughout the study (up to 1 year).

Secondary Outcomes (1)

• Ease of Use

  At visit 2-Day 0, after use of device to insert the implant into the eye.

Study Arms (4)

14.7 mcg (single dose)

EXPERIMENTAL

PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg.

Drug: PA5108 Latanoprost FA SR Ocular Implant

26.6 mcg (single dose)

EXPERIMENTAL

PA5108 Latanoprost FA SR Ocular Implant which releases 26.6 mcg.

Drug: PA5108 Latanoprost FA SR Ocular Implant

35.5 mcg (single dose)

EXPERIMENTAL

PA5108 Latanoprost FA SR Ocular Implant which releases 35.5 mcg.

Drug: PA5108 Latanoprost FA SR Ocular Implant

14.7 mcg (repeat dose)

EXPERIMENTAL

Repeat dose of PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg.

Drug: PA5108 Latanoprost FA SR Ocular Implant

Interventions

PA5108 Latanoprost FA SR Ocular Implant DRUG

Ocular Implant

Also known as: PA5108

14.7 mcg (repeat dose); 14.7 mcg (single dose); 26.6 mcg (single dose); 35.5 mcg (single dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PolyActiva Pty Ltd: lead

Study Sites (9)

PersonalEYES

Castle Hill, New South Wales, 2150, Australia

Location

Goodwood Eye Centre

Millswood, South Australia, 5034, Australia

Location

Bendigo Eye Clinic

Bendigo, Victoria, 3550, Australia

Location

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Essendon Eye Clinic

Essendon, Victoria, 3040, Australia

Location

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

Eyes First

Springvale, Victoria, 3171, Australia

Location

Eye Surgery Associates

Vermont South, Victoria, 3133, Australia

Location

Capital Eye Specialists

Te Aro, 6011, New Zealand

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Michael Coote

  Melbourne Eye Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 19, 2019
• Study Start: March 11, 2020
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8); NZ (1)