An acute clinical comparison of corneal staining and comfort associated with contact lens care solutions

Abstract Purpose This study compared the biocompatibility and comfort of 4 lens care solutions currently marketed in France. Methods This was a randomized, interventional, double-masked, single-center crossover study assessing balafilcon A silicone hydrogel contact lenses, bilaterally, straight from the blister pack solution (control) and pre-soaked in the following lens care solutions: Regard ® (containing sodium chlorite), ReNu ® (containing a PHMB [polyhexamethylene biguanide] derivative), CyClean™ and MeniCare™ Soft (both containing PHMB). Subjects were randomized to the order of test solution use. For each of the 5 solutions tested, subjects attended a baseline/lens dispensing visit and an intervention visit 2 h later. At both visits, evaluation included slit-lamp examination, corrected-distance visual acuity, corneal staining, and subject-assessed photophobia, ocular comfort, and ocular redness. Results Thirty subjects were enrolled and 28 were evaluable. Corneal staining severity was significantly worse than baseline after 2 h of wearing lenses soaked in CyClean, MeniCare, or ReNu ( P  ≤ 0.001). The MeniCare group alone demonstrated a significant improvement in ocular comfort after 2 h of lens wear ( P  = 0.02). No group demonstrated significant changes in ocular redness or photophobia. Corrected-distance visual acuity was similar between baseline and intervention visits for each test solution. No adverse events were reported during the study. Conclusions Silicone hydrogel contact lenses presoaked in lens solutions containing PHMB or a PHMB derivative produced an increase in corneal staining after 2 h of lens wear. The higher levels of corneal staining in the 2 solutions did not correlate with increased discomfort within this 2-h timeframe.