Asymptomatic corneal staining associated with the use of balafilcon silicone-hydrogel contact lenses disinfected with a polyaminopropyl biguanide-preserved care regimen

Optom Vis Sci. 2002 Dec;79(12):753-61. doi: 10.1097/00006324-200212000-00007.

Abstract

Purpose: To compare subjective symptoms and signs in a group of individuals who wear silicone-hydrogel lenses on a daily wear basis while they sequentially used two differing care regimens.

Methods: Fifty adapted soft-lens wearers were fitted with a silicone-hydrogel lens material (PureVision, Bausch & Lomb). The lenses were worn on a daily wear basis for two consecutive 1-month periods, during which the subjects used either a Polyquad (polyquaternium-1) -based system or a polyaminopropyl biguanide (PHMB) -based system, using a double-masked, randomized, crossover experimental design.

Results: Significant levels of relatively asymptomatic corneal staining were observed when subjects used the PHMB-based system, with 37% of subjects demonstrating a level of staining consistent with a classical solution-based toxicity reaction. Only 2% of the subjects exhibited such staining when using the Polyquad-based system. These results were significantly different (p < 0.001). Significant symptoms were not correlated with the degree of staining, with no differences in lens comfort or overall preference being reported between the regimens (p = NS). The only statistically significant difference in symptoms related to minor differences in stinging after lens insertion being reported, with the Polyquad-based system demonstrating less stinging (p < 0.008).

Conclusions: Practitioners who fit silicone-hydrogel contact lenses on a daily wear basis should be wary of the potential for certain PHMB-containing multipurpose care systems to invoke corneal staining. Switching to non-PHMB based regimens will eliminate this complication in most instances.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biguanides / adverse effects*
  • Conjunctiva / blood supply
  • Conjunctiva / pathology
  • Contact Lens Solutions / adverse effects*
  • Contact Lenses, Extended-Wear*
  • Cornea / pathology*
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Hydrogel, Polyethylene Glycol Dimethacrylate*
  • Hyperemia / chemically induced
  • Male
  • Polymers / adverse effects
  • Silicones*
  • Staining and Labeling

Substances

  • Biguanides
  • Contact Lens Solutions
  • Polymers
  • Silicones
  • polyaminopropylbiguanide
  • Hydrogel, Polyethylene Glycol Dimethacrylate
  • polyquaternium 1