NCT03604328

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: PolyActiva Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open-angle Glaucoma

Interventions

Type	Name	Description
DRUG	PA5108	single ocular implant, administered on day 1

Timeline

• Start date: 2018-07-24
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2018-07-27
• Last updated: 2020-09-16

Locations

2 sites across 1 country: Australia