The trial (NCT03319420) in Israel will compare LO2A’s ability to relieve dry eyes with that of an over-the-counter treatment known as Systane Ultra UD. Participants will receive drops in each eye four times a day over three months.
Wize said the study’s primary goal is to see if LO2A improves patients’ dry eye, as measured by changes in their scores on the National Eye Institute/Industry (NEI) Industry Grading System.
The trial’s secondary goals are to see if LO2A can improve patients’ eye disability and tear production. The disability measure will be changes in participants’ Ocular Surface Disease Index (OSDI) questionnaire scores, and the tear production measure changes in patients’ Schirmer’s test scores.
“We are very pleased to commence patient enrollment in this Phase IV study,” Ron Mayron, Wize’s chairman, said in a press release. The company expects “to complete enrollment and treatment of all patients in the fourth quarter of 2018. If the study meets its primary endpoint [objective], we expect this will lead to approval from the Israeli Ministry of Health, which has already approved LO2A for the treatment” of dry eye syndrome in general, Mayron said.
“We are particularly encouraged in this indication because a prior clinical study of LO2A in Hungary demonstrated efficacy in the symptomatic treatment of [dry eye syndrome] in Sjogren’s syndrome patients, which led to LO2A’s approval for Sjogren’s in the Netherlands,” he added.
Sjogren’s patients with dry eye are unable to generate the tear film that protects the eyes’ surface. This makes them more prone to damage to their eyes’ cornea and conjunctiva surfaces.
Wize developed LO2A as a substitute for the tears that lubricate and protect eye surfaces. The treatment has been approved in Europe for more than 10 years. It does not irritate eyes, and can be used with contact lenses.
The company hopes the trial results will lead to the treatment’s approval for the dry eye in Sjogren’s in the U.S., China and Ukraine, as well as Israel.