The trial aimed to compare the investigational drug with the marketed product in subjects following uncomplicated unilateral cataract surgery.
OCT completed an open-label randomized trial in several investigational sites in Russia. A total of about 180 subjects were enrolled. This study included male and female patients aged 18-75 with scheduled unilateral cataract surgery with posterior chamber intraocular lens implantation.
Ophthalmic corticosteroids and nonsteroidal anti-inflammatory drugs for topical administration have been used to minimize the postoperative inflammation and pain associated with cataract surgery. Although current surgical techniques such as phacoemulsification and small-incision cataract surgery with foldable intraocular lenses have decreased the resulting trauma, ocular inflammation can cause patient discomfort, delay postoperative recovery, and may lead to additional complications. The cataract surgical trauma triggers the release of prostaglandins, which in turn cause postoperative ocular inflammation.
Previous phase III clinical trials conducted in Japan, USA, and China demonstrated that the investigational drug effectively minimized or completely eliminated the ocular inflammation. The study in Russia was conducted to support a marketing authorisation application.
In this project, OCT provided a full service support, including medical writing, monitoring, regulatory support, logistics, and registration. In April 2017, the investigational product was included into the State Register of Medicinal Remedies.
The OCT team offers extensive experience in regulatory support and registration of medicinal products. We prepare, write and submit registration dossiers to the Ministry of Healthcare, cooperate with regulatory authorities and provide qualified support during all steps of registration, and coordinate official requests and notes. To learn more about drug registration in Russia and its timeframes, please follow the link.