Contact lens-related adverse events and the silicone hydrogel lenses and daily wear care system used.

OBJECTIVE

To investigate the incidence of adverse events related to the use of varying silicone hydrogel contact lens and lens solution combinations.

METHODS

Individuals with myopia (N = 558) participated in 1 or more of approximately 40-participant trials in a matrix of 20 silicone hydrogel contact lens and lens-solution combinations. Visits were at baseline, 2 weeks, 1 month, and 3 months. The mean study completion rate was 90% of the expected participant-months (final data set: 840 lens-solution combinations and 2271 participant-months). Adverse events were reported as the first occurrence of each type per 100 participant-months for each lens-solution combination.

RESULTS

The rate of all corneal infiltrative events (CIEs) was 3.1 per 100 participant-months (range, 0-10.5), and the rate of symptomatic CIEs was 1.7 per 100 participant-months (range, 0-10.5), including 1 case of microbial keratitis (0.04 per 100 participant-months). Rates for CIEs differed substantially among solution groups, with hydrogen peroxide having the lowest rate (0.6 per 100 participant-months; range, 0-0.9). The rate was 0.8 per 100 participant-months (range, 0-8.0) for superior epithelial arcuate lesions, which varied by lens type, 0.04 per 100 participant-months (1 case only) for corneal erosion, and 0.4 per 100 participant-months (range, 0-2.0) for contact lens papillary conjunctivitis, which was modified by type of solution. The rate of solution-induced corneal staining for all lens-solution combinations was 4.7 per 100 participant-months (range, 0-23) and varied significantly based on lens-solution combination (P < .001).

CONCLUSIONS

The frequency of adverse events varied with silicone hydrogel contact lens and lens solution combinations, with hydrogen peroxide having the lowest incidence of CIEs and solution-induced corneal staining, indicating that lens material and design, type of solution, and solution-lens interactions are likely contributing factors in this mode of lens wear.