This phase 3 trial assessed the safety and efficacy of OTX-101, an aqueous nanomicellar formulation of cyclosporine 0.09% for dry eye disease.

Study design

The study included 744 adults with a history and clinical diagnosis of dry eye. Participants were randomized to receive twice daily OTX-101 or vehicle for 84 days.

Outcomes

The treatment group was more likely than controls to achieve a 10-mm or greater increase in Schirmer test score at day 84 (P<0.001), and to show improvements in corneal and conjunctival staining. The most common adverse event was mild stinging or burning after instillation; no serious events were noted.

Limitations

This study was limited by its relatively short follow up; patients were treated and evaluated for only 12 weeks.

Clinical significance

The new next-generation medications will hopefully allow greater bioavailability with nanomicellar technology. Many people suffer from dry eye disease, and this can be another tool to fight dry eye. Future trials will be required to establish how OTX-101 compares with cyclosporine ophthalmic emulsion 0.05%.