Wize Pharma reported topline results from its Phase IV clinical trial of its in-license eye drop formula, LO2A, for the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.
The randomized, double-masked comparative study evaluated LO2A versus Alcon's Systane® Ultra UD ("comparator"), an over-the-counter lubricant eye drop product used to relieve dry and irritated eyes in DES patients, which is also used to treat dry eye in patients with Sjögren's syndrome.
The study was performed in five centers in Israel and was classified as a Phase IV exploratory study, since LO2A is already approved for marketing in Israel for DES patients.
The study design included 69 patients (138 eyes) with Sjögren's syndrome experiencing DES that were randomized in a 1:1 ratio into two treatment groups, LO2A or Systane® Ultra UD. Drops were administered topically to the eye over a 3-month period.
The primary endpoint of the study was change in corneal staining score, using the National Eye Institute (NEI) Industry Grading System after 3 months of study treatment. This is an objective measure used to determine the severity of the damage caused by dryness of the eye (referred to as "sign").
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Secondary endpoints included a conjunctival staining score after one month of treatment and changes in quality of life with subjective questionnaires, including Ocular Surface Disease Index (OSDI) and Visual Analogue Scale (VAS) score after one and three months of treatment (referred to as "symptoms").
Clinically significant results were defined as a reduction of 3 points in corneal and conjunctival staining and an improvement of 30 points in VAS and of 10 points in OSDI measurements.