12.Dec.2012

OCT is starting a phase III trial in ophthalmology for drug registration in Russia

OCT is initiating a trial in ophthalmology. At the moment OCT is engaged in medical writing of the Protocol and other essential documents to initiate this ophthalmology clinical trial in Russia.

OCT is initiating a trial in ophthalmology. At the moment OCT is engaged in medical writing of the Protocol and other essential documents to initiate this ophthalmology clinical trial in Russia.

The study drug that OCT will be testing is a non-steroidal anti-inflammatory drug. This medicine is already registered in many countries throughout the world. The drug is prescribed for the treatment of ocular inflammation and pain after patients receive cataract surgery.

Although the drug is already registered in some countries, according to the local registration process in Russia we have to perform local studies to get the drug registered.

At the moment OCT is assisting the company with the drug dossier collection and preparation. The drug dossier will be submitted along with the study Protocol. We plan to perform the study at the leading ophthalmology sites in Russia. We have a great network of experienced investigative sites for efficient subject enrollment.

At the moment the drug is a market share leader on the U.S. ophthalmic non-steroidal anti-inflammatory market. We hope that patients in Russia will also have access to this drug soon.

A cataract is a clouding of the lens in the eye that affects vision and brings vision disorders. Usually cataracts are related to person’s aging. Cataracts are very common in the elderly population. For example, by age 80, more than half of all Americans either have a cataract or have had cataract surgery. The operation to remove cataracts can be performed at any stage of their development and is very common in such patients. Age-related cataract is responsible for up to 50% of world blindness, which represents about 18 million people, according to the data from the World Health Organization (WHO).

We have assigned an experienced Project Manager to the study. The PM has a medical degree in ophthalmology. OCT has experience in conducting clinical trials for a wide range of eye diseases. OCT will be responsible for full service in this trial. The client will also be using OCT EDC system in this trial, for the data collection and analysis.