Just a week after the start of initiation of the medical sites for a phase III ophthalmology study, the first patient was enrolled and randomized at one of the sites.
This is a phase III, multicentre, randomized, repeat-dose, open-label, parallel-group study to assess the efficacy and safety of the investigational drug – eye drops – compared to the registered medicinal product, in subjects who have undergone uncomplicated unilateral cataract surgery.
OCT obtained approval for this study conduct from the Ministry of Healthcare of the Russian Federation late February 2014 and it took us less than a month to perform study start-up and randomize the first patient out of the total number of 156 patients that should be enrolled for the current study in 6 investigational sites in Russia.
The primary objective of the current study is to assess the efficacy of the investigational eye drops in the treatment of post-operative ocular inflammation compared to the reference medicinal product which is already registered in the market. The secondary objective is to assess the safety and tolerability of the investigational product compared to the reference one.
Design of the current study has been worked out by OCT medical writers taking into consideration the fact that a number of clinical studies of the investigational eye drops have been already conducted in Asia and the US by the Sponsor of the study in order to assess safety, tolerability and efficacy of the product and to investigate a variety of clinical applications and indications.
Cataract, which is clouding of the lens of the eye preventing clear vision, is one of the major reasons for poor eyesight and other vision problems, including ablepsia, in millions of people all over the world, and Russia is not an exception. However, actions are being taken by the healthcare community to prevent and support visual impairment treatment. Thus, in 2013 the World Health Assembly approved a plan of activities to provide support to patients with eyesight problems for 2014-2019. The actions taken have already shown results – more patients have started to consult doctors to identify and treat ocular diseases.
According to statistics, about 400 thousands of surgeries are made in Russia each year in patients suffering from cataract. Of course, this figure is far from a real need, however, it confirms that Russia is a favorable region for the current phase III study in patients who have undergone uncomplicated unilateral cataract surgery, and OCT is confident in fast enrollment of the remaining 155 patients for this clinical trial.