Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma

An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03604328

Enrollment

Registered

2018-07-27

Start date

2018-07-24

Completion date

2020-06-15

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma

Brief summary

A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).

Detailed description

Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Interventions

DRUGPA5108

single ocular implant, administered on day 1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale) * Visual acuity in non-study eye same or better than study eye * Currently taking topical ocular hypotensive medication including a prostaglandin analogue

Exclusion criteria

* Aphakic eyes * Only one eye * History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema * Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period * Current retinal detachment * Uncontrolled infection in the eye

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as measured by the occurrence of adverse events	4 weeks

Secondary

Measure	Time frame
Timeframe to complete implant biodegradation based on implant size and location	6 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026