Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease

This was a 4 week phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of cenegermin ophthalmic solution at 20 mcg/mL solution versus vehicle, in patients with severe Sjogren's dry eye disease under treatment with Ciclosporine A (or other drugs of the same class).

During the Screening all procedures for inclusion and exclusion were performed. From the day of screening, the patients stopped any kind of further treatment, except CsA and commercially available preservative-free artificial tears provided by the Sponsor for a period of 8 days and 10 days as maximum. At the end of the washout period, patients still meeting the entry criteria for this study were randomized 1:1 and treated for 4 weeks with either cenegermin ophthalmic solution 20 mcg/mL three times a day (TID) or vehicle TID.

In addition to topical CsA eye drops (both groups continued with topical CsA eye drops, or other topical ophthalmic treatment of the same class), during the 4 weeks of masked treatment, only the administration of investigational medicinal product (IMP) was allowed.

During the follow up period, the patient could administer additional preservative-free artificial tear eye drops, provided by the Sponsor, only if strictly needed, and had to document in the patient's Diary the number of additional drops administered for each eye.

Patients were then followed-up for efficacy and safety endpoints until Week 16 and for safety endpoints until Week 24.

The total duration of the study was 25 weeks including 1 week of screening.