Clinical Trials
Polyactiva
An open-label study to evaluate the efficacy, safety, tolerability, and biodegradation period of PA5346 Ocular Implant, 115mcg when administered to patients with Open-Angle Glaucoma or Ocular Hypertension.
Overview
This research study is testing a new potential treatment called PA5346 for Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
PA5346 Ocular Implant releases an already approved pharmaceutical product, latanoprost, for the treatment of OAG and OHT.
PA5346 is not approved in the current implant formulation anywhere in the world and requires clinical testing.
Glaucoma is characterised by damage to the optic nerve at the back of the eye and is managed by lowering the fluid pressure in your eye.
Higher eye fluid pressure is often treated with eye drops, which are effective for many people but cause side effects and require patients to ensure they are using their drops every day.
Many patients do not prefer to use drops or do not use them regularly as they should.
This means that their treatment is not as effective as it should be.
PA5346 Ocular Implant is a small, clear, rod-shaped implant that is placed in the anterior (front) chamber of the eye and slowly releases a drug called latanoprost over a period of approximately 52 weeks.
The implant has been designed to degrade or dissolve (naturally breakdown at the end of the treatment period), so there is no need for it to be removed from the eye.
If the implant is proven to work effectively, it could significantly improve the treatment of glaucoma by controlling the fluid pressure in the eye, and ensuring that patients always receives the daily dose of latanoprost that they need without the use of daily eye drops.
The aims of this study are to determine how effective and safe a single dose of 115 microgram (mcg) PA5346 Ocular Implant is, as well as how long it lasts in the eye.
The duration of this study is 15 months.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Professor Keith Martin
This research study is testing a new potential treatment called PA5346 for Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
PA5346 Ocular Implant releases an already approved pharmaceutical product, latanoprost, for the treatment of OAG and OHT.
PA5346 is not approved in the current implant formulation anywhere in the world and requires clinical testing.
Glaucoma is characterised by damage to the optic nerve at the back of the eye and is managed by lowering the fluid pressure in your eye.
Higher eye fluid pressure is often treated with eye drops, which are effective for many people but cause side effects and require patients to ensure they are using their drops every day.
Many patients do not prefer to use drops or do not use them regularly as they should.
This means that their treatment is not as effective as it should be.
PA5346 Ocular Implant is a small, clear, rod-shaped implant that is placed in the anterior (front) chamber of the eye and slowly releases a drug called latanoprost over a period of approximately 52 weeks.
The implant has been designed to degrade or dissolve (naturally breakdown at the end of the treatment period), so there is no need for it to be removed from the eye.
If the implant is proven to work effectively, it could significantly improve the treatment of glaucoma by controlling the fluid pressure in the eye, and ensuring that patients always receives the daily dose of latanoprost that they need without the use of daily eye drops.
The aims of this study are to determine how effective and safe a single dose of 115 microgram (mcg) PA5346 Ocular Implant is, as well as how long it lasts in the eye.
The duration of this study is 15 months.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator