The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
249
Investigational soft contact lenses
Commercially available soft contact lenses
Hydrogen peroxide-based cleaning and disinfecting solution
Alcon Investigator 8103
Glendale, Arizona, United States
Alcon Investigator 8101
Brentwood, California, United States
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time frame: Week 1 Follow-Up
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.
Time frame: Week 1 Follow-Up, at least 4 hours after lens insertion
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Alcon Investigator 8102
Irvine, California, United States
Alcon Investigator 8135
Los Angeles, California, United States
Alcon Investigator 8108
Novato, California, United States
Alcon Investigator 8062
Oakland, California, United States
Alcon Investigator 8109
San Francisco, California, United States
Alcon Investigator 6565
Maitland, Florida, United States
Alcon Investigator 6355
Orlando, Florida, United States
Alcon Investigator 8115
Norcross, Georgia, United States
...and 8 more locations