In a dose-response safety and efficacy trial, researchers compared different concentrations of NCX 470 (a nitric oxide–donating bimatoprost) to latanoprost. Adults with bilateral open-angle glaucoma or ocular hypertension were randomly assigned to 1 of 4 treatments: NCX 470 0.021% (n=111), 0.042% (n=108), 0.065% (n=107), or latanoprost 0.005% (n=107). At weeks 1, 2, and 4, IOP was measured at 8:00 am, 10:00 am, and 4:00 pm. The primary efficacy endpoint was the reduction in mean diurnal IOP from baseline at week 4. Secondary efficacy endpoints included mean diurnal IOP reductions from baseline at weeks 1 and 2 and time-matched IOP reductions from baseline at 8:00 am, 10:00 am, and 4:00 pm at weeks 1, 2, and 4. Adverse events were investigated. All NCX 470 concentrations resulted in significant reductions in mean diurnal IOP. For a change from baseline in mean diurnal IOP at week 4, the 0.042% and 0.065% concentrations were statistically superior to latanoprost 0.005%, and 0.021% was non-inferior to latanoprost. At week 4, the 0.065% concentration outperformed latanoprost by up to 1.4 mm Hg for reduction from baseline at 8:00 am, 10:00 am, and 4:00 pm. NCX 470 was well tolerated and safe; conjunctival hyperemia was the most frequently reported adverse event. IOP was reduced by NCX 470 in a dose-dependent manner. At week 4, the 0.042% and 0.065% concentrations showed significantly greater reductions from baseline in mean diurnal IOP than latanoprost 0.005 percent, implying that higher concentrations may be even more effective.
