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

• Status: Completed
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: PolyActiva Pty Ltd

Criteria

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