title: Mucin Balls Influence Corneal Infiltrative Events.
abstract: To determine whether mucin ball (MB) formation is protective against corneal infiltrative events (CIEs) as previously reported.
  
  
  
  Two hundred eighty-two eligible participants were enrolled at three sites in the USA. Participants began a 1-month continuous wear run-in period with high modulus lotrafilcon A lenses to assess their ability to form MBs (phase 1). Subsequently, they were stratified by this characteristic and randomized to balafilcon A or comfilcon A lenses for 7-day extended wear and followed for 1 year (phase 2). MB formation in each phase was defined as repeated presence of any MBs on a person level. Multivariable Cox proportional hazards regression was used to model the probability of a CIE as a function of MB formation in each phase and other covariates.
  
  
  
  Of the 282 participants who entered phase 1, 218 of them entered the phase 2 randomized trial during which 33 CIEs occurred. Overall, 74%, 61%, and 79% of participants repeatedly produced MBs in lotrafilcon A, balafilcon A, and comfilcon A lenses, respectively. Early repeated MB presence in phase 1 with lotrafilcon A lenses significantly increased the rate of CIEs in phase 2 (12-month follow-up) by 466% (HR 4.66, 95% confidence interval 1.10-19.79, P = .0372). Repeated, longer-term MB presence during wear of balafilcon A or comfilcon A in phase 2 did not significantly reduce the incidence of CIEs; however, it significantly decreased the rate of CIEs by 62% (hazard ratio (HR) 0.380, 95% confidence interval 0.145-0.998, P = .0494).
  
  
  
  The overarching hypothesis that MB formation is protective against CIEs throughout extended wear was not supported. Although a protective effect of longer-term MB presence on rate of CIEs was detected, early-onset MB formation substantially increased the hazard for CIE in subsequent wear with different lens types.
authors.affiliation: *OD, PhD, FAAO †MD, MS ‡OD, FAAO §PhD University Hospitals Eye Institute, University Hospitals Case Medical Center, Cleveland, Ohio (LS-F); Departments of Ophthalmology & Visual Sciences (LS-F) and Epidemiology & Biostatistics (SD, YJ), Case Western Reserve University, Cleveland, Ohio; Western Reserve Vision Care, Beachwood, Ohio (MJS); The Ohio State University College of Optometry, Columbus, Ohio (DOM, JJW); and Johnson & Johnson Vision Care, Inc., Jacksonville, Florida (TW).
authors.forename: Loretta B
authors.initials: LB
authors.lastname: Szczotka-Flynn
authors.forename: Ying
authors.initials: Y
authors.lastname: Jiang
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Stiegemeier
authors.forename: Donald O
authors.initials: DO
authors.lastname: Mutti
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Walline
authors.forename: Tawnya
authors.initials: T
authors.lastname: Wilson
authors.forename: Sara
authors.initials: S
authors.lastname: Debanne
mesh_terms: D000328:Adult; D001419:Bacteria / Q000302:isolation & purification*; D015169:Colony Count, Microbial; D003262:Contact Lenses, Extended-Wear / Q000382:microbiology*; D003320:Corneal Ulcer / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D015818:Eye Infections, Bacterial / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020100:Hydrogels; D008297:Male; D009077:Mucins / Q000502:physiology*; D016016:Proportional Hazards Models; D012307:Risk Factors; D012828:Silicones
chemical_list: D020100:Hydrogels; D009077:Mucins; D012828:Silicones; C523195:balafilcon A; C540498:comfilcon A