This is a double-masked, randomized, multi-center, parallel-group comparative study of efficiency and safety of the investigational drug in patients with ocular inflammation following cataract surgery.
Two groups of patients, 93 patients in each, 186 in total, are planned to be enrolled for this study in Russia.
The investigational product is an anti-inflammatory eye drop (sodium hydrate ophthalmic solution 0,1%) that has been already marketed in Japan and China.
OCT is to provide the full range of services in the framework of the discussed project, starting with Medical Writing and Regulatory application preparation and compilation, Clinical Monitoring and full Project Management through final study report, including Data Management and Biostatistics.
OCT has extensive experience in the organization and conduct of phase III, “pivotal", studies. Significant patients’ population is one of the reasons why countries of OCT operation (especially Russia and Central and Eastern Europe) are specifically attractive for the late phase clinical trials conducted by international pharmaceutical and biotechnology companies.
This patients’ population is known to be drug naive in a number of therapeutic areas, at least they have not been exposed to many new western drugs. Moreover, patients here are highly motivated to participate in clinical trials due to the fact that such participation could offer otherwise unavailable treatment opportunities.
About 40 phase III clinical trials have been conducted by OCT team since 2005, including a number of ophthalmology studies.
Close relations with a number of key opinion leaders and highly qualified investigators all over Russia and other countries of OCT operation (Ukraine, Belorussia, Bulgaria, Latvia, Lithuania, Estonia, US) helps us guarantee high enrollment speed as well as the appropriate quality of the data obtained as a result of the trials conducted in our region.
We would remind that the process of approval receipt if done within registration procedure at the Ministry of Healthcare of the Russian Federation includes the following steps:
Preparation of the package of documents necessary for a submission in both paper and electronic form at the rosminzdrav portal
After the state duty is paid, the package is submitted to the Ministry of Healthcare of the Russian Federation (MoH)
The Dossier is examined by the MoH, the Ethics Committee and the Scientific Center of Medical Products Expert Examination. If a positive decision is made by the experts, it can be found in the personal account at rosminzdrav portal
Then, the second package of documents for a clinical trial approval should be prepared in paper and electronic forms and submitted to the MoH again. This is followed by obtaining an approval for a clinical trial conduct.