title: A 12-month prospective clinical trial of comfilcon A silicone-hydrogel contact lenses worn on a 30-day continuous wear basis.
abstract: OBJECTIVE
  To evaluate the clinical performance of comfilcon A (Biofinity) during 12 months of continuous wear compared to other silicone-hydrogel lenses.
  
  
  METHODS
  Forty-five subjects were fitted in one eye with the comfilcon A (test) lens. For 22 subjects, the other eye was fitted with lotrafilcon A (group A) and for the remaining 23 subjects the other eye was fitted with balafilcon A (group B). Twelve-month data are presented on 48 measured variables.
  
  
  RESULTS
  There were no serious adverse events during the course of the study. A total of 33 subjects completed the study, with only 4 discontinuations for lens-related reasons, spread proportionately between the lenses. On preference scales, the test lens was superior to both control lenses for comfort (p<0.05) and overall preference (p<0.05) and in group A for vision (p<0.05). On grading scales, the test lens scored better than both control lenses for overall comfort (p<0.1 for group A, p<0.05 for group B), comfort during the day (p<0.05), end-of-day comfort (p<0.05) and overall preference (p<0.05), and better in group A for general vision quality (p<0.01), night vision quality (p<0.01) and handling (p<0.05). All lenses performed to a comparable degree on the basis of microcysts and corneal staining. There were significant differences between lenses in producing limbal redness (p<0.05), bulbar conjunctival hyperemia (p<0.1) and conjunctival NaFl staining (p<0.01) with the control lens in group A showing the greatest effect and the control lens in group B the least.
  
  
  CONCLUSIONS
  Comfilcon A offers performance advantages over first generation silicone-hydrogel materials for continuous wear.
authors.affiliation: Brennan Consultants Pty Ltd., 110 Auburn Rd, Auburn Village, Melbourne 3122, Australia. nbrennan@brennanconsultants.com.au
authors.forename: Noel A
authors.initials: NA
authors.lastname: Brennan
authors.forename: M-L Chantal
authors.initials: ML
authors.lastname: Coles
authors.forename: Heather R M
authors.initials: HR
authors.lastname: Connor
authors.forename: Robert G
authors.initials: RG
authors.lastname: McIlroy
mesh_terms: D000328:Adult; D003228:Conjunctiva / Q000098:blood supply / Q000473:pathology; D003262:Contact Lenses, Extended-Wear / Q000009:adverse effects; D003315:Cornea / Q000473:pathology; D003560:Cysts / Q000209:etiology; D005128:Eye Diseases / Q000209:etiology; D005260:Female; D006801:Humans; D020100:Hydrogels; D006940:Hyperemia / Q000209:etiology; D008297:Male; D017060:Patient Satisfaction; D012828:Silicones; D013194:Staining and Labeling; D014785:Vision, Ocular
chemical_list: D020100:Hydrogels; D012828:Silicones