Investigators evaluated a water-free cyclosporine formulation (CyclASol) for moderate to severe dry eye disease.

Study design

This was a multicenter, randomized, vehicle-controlled, double-masked phase 2 trial. Researchers randomized 207 patients with dry eye to receive 2 daily doses of CyclASol (0.05% or 0.1%), vehicle, or open-label Restasis (cyclosporine ophthalmic emulsion) for 16 weeks.

Outcomes

CyclASol treatment consistently improved corneal and conjunctival staining relative to vehicle and Restasis. At week 4, both 0.05% and 0.1% CyclASol groups had significantly reduced corneal fluorescein staining (-1.92 and -1.88, respectively) compared with Restasis (-0.85). Central corneal staining was significantly reduced in the CyclASol groups (-0.34 and -0.31) over Restasis (0.06). Some effects occurred as early as 2 weeks.

Overall, 65 patients exhibited mild to moderate adverse events. There were no differences in signs, symptoms, or safety of the 2 CyclASol concentrations.

Limitations

Since the medication was not masked from the patient—Restasis was white while the other was clear—there may have been a brand bias.

Clinical significance

This new cyclosporine formulation demonstrated excellent safety, tolerability, and comfort profile. These findings may prompt a movement to start patients on this formulation, especially since it acts sooner than a traditional vehicle.