Purpose:
To determine if corneal staining and comfort associated with FDA group II soft contact lenses disinfected by various care regimens vary with time post-insertion.
Methods:
Twenty soft lens-wearing subjects were enrolled into this investigator-masked, randomized, cross-over study. Subjects were fitted with Bausch & Lomb SofLens* 66 (Alphafilcon; FDA group II) lenses and randomly used three multi-purpose solutions (MPS) - OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution (OFX; Alcon); Complete MoisturePLUS* MPS (COM; Advanced Medical Optics) and ReNu MultiPlus*; MPS (RNU; Bausch & Lomb) for consecutive 2-week periods, with new lenses dispensed with each regimen. Subjects were examined at baseline and at 1 day, 1 week and 2 weeks with each regimen. On each visit day, staining and comfort were rated after 2 and 6 hours of lens wear. In addition, lens comfort was graded at the beginning, middle and end of the day.
Results:
Corneal staining occurred most frequently and at the greatest severity with RNU and least with OFX (P < 0.001). OFX showed no significant change in staining (P = NS), with RNU and COM showing greater staining at 2 hours than at 6 hours (P < 0.001). At all follow-up visits, COM and RNU demonstrated more staining than OFX (P < 0.001). The staining varied from a low grade, micropunctate pattern to clinically significant diffuse staining requiring cessation of lens wear. Subjective comfort ratings decreased significantly from beginning to end of the day (P < 0.001) with no significant differences between the three regimens (P = NS). There was no significant correlation between corneal staining and comfort at any time of the day (P = NS).
Conclusion:
Significant corneal staining can occur with certain FDA group II lenses when used with certain MPSs, but this staining does not appear to influence comfort levels. Lens comfort is not a predictor of corneal health. Patients who experience good lens comfort should have a comprehensive slit lamp examination to evaluate corneal staining. This is particularly relevant after two hours of lens wear, when maximal solution sensitivity appears to be represented.
Citation: