The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 3 commercially available contact lens cleaning and disinfecting solutions in a pediatric population. This study will be conducted in Canada and the US.
Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.
Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.
Multi-purpose disinfecting solution (MPDS) used for cleaning, disinfecting, and storage of soft contact lenses; commercially available in country of conduct.
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Front surface deposits at Day 90
Protein and lipid deposits on the front surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Time frame: Day 90
Back surface deposits at Day 90
Protein and lipid deposits on the back surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Time frame: Day 90
Incidence of corneal infiltrative events
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. Corneal infiltrative events will be detected by the investigator during an eye exam.
Time frame: Up to Day 90
Incidence of microbial keratitis
Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam.
Time frame: Up to Day 90
Incidence of solution induced corneal staining (SICS)
Corneal staining determined by the investigator to be solution-related will be graded by type (pattern of staining) and area (how much) in each of the 5 corneal regions: central, superior, nasal, inferior, temporal.
Time frame: Up to Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Daily wear, reusable, soft (including hydrogel and silicone hydrogel) contact lenses according to subject's habitual prescription worn in both eyes and removed prior to sleep for cleaning and disinfection with the study product provided.