This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
218
FDA approved soft contact lenses
Department of Ophthalmology University Hospitals Case Medical Center
Cleveland, Ohio, United States
Number of Participants Developing a Corneal Inflammatory Event (CIE)
Raw number of participants in each solution arm developing CIE over 12 month follow-up period
Time frame: up to 1 year
Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses
Time frame: up to 1 year
Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones
Time frame: up to 1 year
Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora
Time frame: up to 1 year
Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids
Time frame: up to 1 year
Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids
Time frame: up to 1 year
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