title: Effect of Daily Contact Lens Cleaning on Ocular Adverse Events during Extended Wear.
abstract: OBJECTIVE
  The purpose of the study was to assess what effect daily cleaning of contact lenses with a multipurpose disinfection solution (MPDS), during 30 nights extended wear, would have on contact lens-related adverse events.
  
  
  METHODS
  This was a prospective, open-label, randomized, controlled, parallel-group, 3-month clinical study in which 193 participants were dispensed with lotrafilcon A silicone hydrogel lenses for a 30-day extended-wear schedule and with lenses replaced monthly. Participants were randomized to a control or test group. Test subjects were required to remove lenses daily after waking, clean them with the MPDS, and reinsert the lenses. Control subjects wore lenses without removal for 30 days extended wear. Handling-related lens contamination was assessed at the baseline visit.
  
  
  RESULTS
  There was no significant difference between the test and control groups for the incidence of significant corneal infiltrative events (1.3 vs. 4.9%, p = 0.368), total corneal infiltrative events (2.6 vs. 4.9%, p = 0.682), or mechanical events (1.3 vs. 2.5%, p = 1.00). The test group had greater corneal staining (p < 0.047) and fewer mucin balls (p = 0.033). Handling-related lens contamination (unworn lenses) resulted in isolation of Gram-positive bacteria from 92.5% of test lenses compared with 87.5% of control lenses (p = 0.712). Gram-negative bacteria were isolated from 5% of test subjects compared with 2.5% of control subjects (p = 1.00). Fungus was isolated from 2.5% of subjects in both the test and control groups (p = 1.00).
  
  
  CONCLUSIONS
  The intervention of daily morning cleaning of the lens surface with an MPDS during extended wear did not significantly influence the incidence of adverse events.
authors.affiliation: *BOptom †MBBS, DO ‡PhD, FAAO §MBiostat, PhD ∥PhD, DSc, FAAO Brien Holden Vision Institute, Sydney, New South Wales, Australia (JO, PLD, TN, BAH); L. V. Prasad Eye Institute, Hyderabad, Andhra Pradesh, India (VMR); School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia (JO, PLD, BAH, MDPW); and Vision Co-operative Research Centre, Sydney, New South Wales, Australia (JO, PLD, TN, BAH).
authors.forename: Jerome
authors.initials: J
authors.lastname: Ozkan
authors.forename: Varsha M
authors.initials: VM
authors.lastname: Rathi
authors.forename: Percy Lazon
authors.initials: PL
authors.lastname: de la Jara
authors.forename: Thomas
authors.initials: T
authors.lastname: Naduvilath
authors.forename: Brien A
authors.initials: BA
authors.lastname: Holden
authors.forename: Mark D P
authors.initials: MD
authors.lastname: Willcox
mesh_terms: D000293:Adolescent; D015169:Colony Count, Microbial; D018639:Contact Lens Solutions / Q000627:therapeutic use*; D003262:Contact Lenses, Extended-Wear / Q000009:adverse effects* / Q000382:microbiology*; D015818:Eye Infections, Bacterial / Q000209:etiology*; D005260:Female; D005658:Fungi / Q000302:isolation & purification*; D006090:Gram-Negative Bacteria / Q000302:isolation & purification*; D006094:Gram-Positive Bacteria / Q000302:isolation & purification*; D006235:Hand Disinfection; D006801:Humans; D020100:Hydrogels; D015994:Incidence; D008297:Male; D011446:Prospective Studies; D012828:Silicones; D005466:Fluorocarbons
chemical_list: D018639:Contact Lens Solutions; D020100:Hydrogels; D012828:Silicones; C481129:lotrafilcon A; D005466:Fluorocarbons