Florence Malet1. 1. CHU Bordeaux, Hôpital Pellegrin, Département d'Ophtalmologie, Bordeaux, France. Electronic address: Florence.malet@chu-bordeaux.fr.
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 2h 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 2h of wearing lenses soaked in CyClean, MeniCare, or ReNu (P≤0.001). The MeniCare group alone demonstrated a significant improvement in ocular comfort after 2h 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 2h of lens wear. The higher levels of corneal staining in the 2 solutions did not correlate with increased discomfort within this 2-h timeframe.
RCT Entities:
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 2h 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 2h of wearing lenses soaked in CyClean, MeniCare, or ReNu (P≤0.001). The MeniCare group alone demonstrated a significant improvement in ocular comfort after 2h 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 2h of lens wear. The higher levels of corneal staining in the 2 solutions did not correlate with increased discomfort within this 2-h timeframe.