The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Investigational silicone hydrogel contact lens
Commercially available silicone hydrogel contact lens
Alcon Investigator 6402
Medina, Minnesota, United States
Alcon Investigator 8046
Granville, Ohio, United States
Alcon Investigator 2786
Memphis, Tennessee, United States
Distance Visual Acuity (VA) With Study Lenses
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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
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