title: The comparative clinical performance of a new polyhexamethylene biguanide- vs a polyquad-based contact lens care regime with two silicone hydrogel contact lenses.
abstract: OBJECTIVE
  To compare the clinical performance of a new polyhexamethylene-biguanide (PHMB)- vs a polyquad-based contact lens care regime with two silicone hydrogel contact lenses.
  
  
  METHODS
  This study was a randomised, controlled and investigator-masked (to the lens regimen) clinical study where the clinical performance of two multipurpose contact lens solutions was compared at a single site. Forty-one existing contact lens wearers were recruited and fitted randomly with either galyfilcon A or lotrafilcon A contact lenses. Subjects wore the same lens type for a period of 2 months but used a different care regime (PHMB- and polyquad-based) in a crossover manner, each for a period of 1 month. The primary outcome measure was the difference in corneal staining. Corneal staining was graded in five different locations: central, superior, inferior, temporal and nasal. Measurements of conjunctival redness, limbal redness, conjunctival staining and papillary conjunctivitis were also carried out throughout the study. Biomicroscopic measures were graded using the Efron grading scales. A variety of symptoms were also measured using a visual analogue scale.
  
  
  RESULTS
  There was no statistically significant difference in overall corneal staining between lens types (p = 0.16) or care regimens (p = 0.60). Central corneal staining was significantly greater for the polyquad-based care regimen when compared with the PHMB-based care regimen (p = 0.04). Lotrafilcon A lenses showed greater superior corneal staining (p = 0.0004) and papillary conjunctivitis (p = 0.02), and lower comfort on insertion (p = 0.03) when compared with galyfilcon A lenses regardless of the care regime used. There were no statistically significant differences in the other biomicrosopic signs and symptoms between the lens types and the care regimes.
  
  
  CONCLUSIONS
  Both care regimes performed in a similar clinical manner and are valid for use with the two silicone hydrogel contact lenses used in this study.
authors.affiliation: Menicon Co., Ltd, 21-19, Aoi 3 Naka-Ku, Nagoya 460-0006, Japan. j.santodomingo@menicon-net.co.jp
authors.forename: Jacinto
authors.initials: J
authors.lastname: Santodomingo-Rubido
mesh_terms: D000293:Adolescent; D000328:Adult; D001645:Biguanides; D018639:Contact Lens Solutions / Q000009:adverse effects*; D003261:Contact Lenses; D004202:Disinfectants; D006801:Humans; D020100:Hydrogels; D008875:Middle Aged; D017060:Patient Satisfaction; D011108:Polymers; D020034:Silicone Gels
chemical_list: D001645:Biguanides; D018639:Contact Lens Solutions; D004202:Disinfectants; D020100:Hydrogels; D011108:Polymers; D020034:Silicone Gels; C031233:polihexanide; C058655:polyquaternium 1