A phase 4 clinical trial of LO2A for the symptomatic treatment of dry eye syndrome in patients with Sjögren’s syndrome has enrolled its first patient in Israel, according to a press release from Wize Pharma.
The randomized, double-masked study will include 60 patients with Sjögren’s syndrome. One group of patients will receive LO2A and the other will receive Systane Ultra UD (Alcon) over-the-counter lubricant eye drops over 3 months.
The study’s primary endpoint is change in corneal/conjunctival staining score after 3 months, and secondary endpoints are corneal/conjunctival staining score after 1 month and change in Ocular Surface Disease Index score after 1 month and 3 months.
The study is designed to meet marketing approval requirements in Israel and may also be used for the clinical approval pathway for LO2A for dry eye syndrome in Sjögren’s syndrome in markets such as the United States, China and Ukraine. LO2A is already approved in Israel for dry eye syndrome.