Corneal inflammatory events with daily silicone hydrogel lens wear.
OBJECTIVE
This study aimed to determine the probability and risk factors for developing a corneal inflammatory event (CIE) during daily wear of lotrafilcon A silicone hydrogel contact lenses.


METHODS
Eligible participants (n = 218) were fit with lotrafilcon A lenses for daily wear and followed up for 12 months. Participants were randomized to either a polyhexamethylene biguanide-preserved multipurpose solution or a one-step peroxide disinfection system. The main exposures of interest were bacterial contamination of lenses, cases, lid margins, and ocular surface. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted probability of remaining free from a CIE, and multivariate Cox proportional hazards regression was used to model the hazard of experiencing a CIE.


RESULTS
The KM unadjusted cumulative probability of remaining free from a CIE for both lens care groups combined was 92.3% (95% confidence interval [CI], 88.1 to 96.5%). There was one participant with microbial keratitis, five participants with asymptomatic infiltrates, and seven participants with contact lens peripheral ulcers, providing KM survival estimates of 92.8% (95% CI, 88.6 to 96.9%) and 98.1% (95% CI, 95.8 to 100.0%) for remaining free from noninfectious and symptomatic CIEs, respectively. The presence of substantial (>100 colony-forming units) coagulase-negative staphylococci bioburden on lid margins was associated with about a five-fold increased risk for the development of a CIE (p = 0.04).


CONCLUSIONS
The probability of experiencing a CIE during daily wear of lotrafilcon A contact lenses is low, and symptomatic CIEs are rare. Patient factors, such as high levels of bacterial bioburden on lid margins, contribute to the development of noninfectious CIEs during daily wear of silicone hydrogel lenses.
*OD, PhD, FAAO †MD ‡BSOptom §PhD ∥MS **MD, PhD ††PhD, MBA University Hospitals Eye Institute, University Hospitals Case Medical Center (LS-F), Cleveland, Ohio; Departments of Ophthalmology & Visual Sciences (LS-F, SR), Epidemiology & Biostatistics (LS-F, YJ, RAB, SMD), and Pathology (MRJ) and Division of Information Technology Services (RAB, MTG), Case Western Reserve University, Cleveland, Ohio; and Alcon Laboratories (JK), Fort Worth, Texas.
Loretta
L
Szczotka-Flynn
Ying
Y
Jiang
Sangeetha
S
Raghupathy
Roger A
RA
Bielefeld
Matthew T
MT
Garvey
Michael R
MR
Jacobs
Jami
J
Kern
Sara M
SM
Debanne
D000293:Adolescent; D000328:Adult; D001422:Bacterial Adhesion / Q000502:physiology*; D015331:Cohort Studies; D018639:Contact Lens Solutions / Q000627:therapeutic use; D003263:Contact Lenses, Hydrophilic / Q000382:microbiology* / Q000706:statistics & numerical data; D003320:Corneal Ulcer / Q000453:epidemiology / Q000382:microbiology*; D004311:Double-Blind Method; D004866:Equipment Contamination / Q000517:prevention & control / Q000706:statistics & numerical data*; D015818:Eye Infections, Bacterial / Q000453:epidemiology / Q000382:microbiology*; D005260:Female; D006801:Humans; D020100:Hydrogels; D015994:Incidence; D008297:Male; D011336:Probability; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D012828:Silicones; D005466:Fluorocarbons
D018639:Contact Lens Solutions; D020100:Hydrogels; D012828:Silicones; C481129:lotrafilcon A; D005466:Fluorocarbons