RecruitingPhase 1ACTRN12621001718831

Phase I study of a Latanoprost Ocular Implant for treatment of Open Angle Glaucoma or Ocular Hypertension.

Open label study to evaluate the safety, tolerability and biodegradation period of PA5346 Latanoprost Free Acid (FA) Sustained Release (SR) Ocular Implant when administered to patients with Open Angle Glaucoma or Ocular Hypertension.

Sponsor

PolyActiva Pty Ltd

Enrollment

6 participants

Start Date

Dec 20, 2021

Study Type

Interventional

Conditions

Open Angle Glaucoma Ocular Hypertension

Summary

A multi centre, open label study to assess the safety and tolerability of PA5346 ocular implant in adults who have Open Angle Glaucoma or Ocular Hypertension. Participants who are currently administering Intraocular Pressure lowering drop therapy for Open Angle Glaucoma or Ocular Hypertension 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 PA5346 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Glaucoma and ocular hypertension are conditions where the pressure inside the eye is too high, which can damage the optic nerve and lead to vision loss over time. Most people manage this with eye drops applied daily, but remembering to use them consistently can be challenging, and some people experience side effects from the drops. This study tests a new ocular implant called PA5346, which is a small biodegradable device injected into the eye that slowly releases latanoprost — the same medication found in many commonly used glaucoma eye drops. The implant aims to lower eye pressure continuously without the need for daily drops. This early-phase trial focuses on safety and tolerability. You may be eligible if you are 18 or older, have open-angle glaucoma or ocular hypertension, are currently using eye drop therapy including a prostaglandin analogue, and have eye pressure in the specified range after stopping drops. People with only one functioning eye, recent eye surgery, certain types of glaucoma, or specific corneal conditions are not eligible. The study will monitor the implant until it fully dissolves in the eye.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PA5346 ocular implant is a small, clear rod-shaped implant that is placed in the anterior (front) chamber of the eye, at a single timepoint, and slowly releases a drug called latanoprost free acid (100ng/day) over a period of approximately 30 weeks. The implant has been designed to slowly disappear (naturally breakdown and be reabsorbed back into the body), so there is no need for it to be removed. If the implant is proven to work effectively, it could significantly improve the treatment of glaucoma by substituting for eye drops to control the pressure in the eye, and ensure the patient always receives the daily dose of latanoprost free acid that they need. All administrations of the ocular implant will be undertaken by a qualified and trained ophthalmologist.