RegeneRx Biopharmaceuticals has completed patient recruitment in a placebo-controlled, double-masked Phase 2 trial to evaluate the safety and efficacy of RGN-259 as a treatment of dry eye syndrome.
In total, the company has recruited 72 patients in the trial and expects to conclude treatment by its stipulated time line.
RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications, or placebo will be given twice daily for 30 days.
Signs and symptoms of dry eye, such as the degree of ocular surface damage, ocular itching, burning and grittiness, among others, will be graded periodically during and following the treatment period.
The trial is being conducted by ORA, an ophthalmic contract research organization that specializes in dry eye research and clinical trials.
The results from previous human studies suggested that RGN-259 can successfully heal ocular surface defects, which most often occur as a result of dry eye syndrome and particularly in patients with moderate-to-severe dry eye.