Phase 2 Clinical Trial

Goal: Test whether Lacripep™ restores health to eyes of patients with Primary Sjögren’s Syndrome dry eye (NCT03226444).

About: The study lasted 8 weeks and included 5 visits to an ophthalmologist. Patients were provided with ophthalmic drops of Lacripep™ or placebo. Lacripep™ is a synthetic tear protein fragment of ‘lacritin’. Lacritin and a natural version of Lacripep™ are constituents of normal human tears but are lacking in dry eye tears. In preclinical studies, both restore tearing and eye health. The study was restricted to patients with Primary Sjögren’s Syndrome dry eye. Patients stopped treatment of Restasis or Xiidra two weeks before. Those with punctal plugs inserted two weeks before or later were not excluded. Those on serum tears ceased treatment 30 days before.

Trial Sites: ~35 private and academic clinics in 17 different states.

Status: Enrollment complete.  Results expected in Spring 2020.