The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
FDA-cleared silicone hydrogel toric contact lenses used as indicated
Commercially available silicone hydrogel toric contact lenses used as indicated
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Sabal Eye Care
Longwood, Florida, United States
Drs. Giedd, P.A.
Maitland, Florida, United States
Vision Health Institute
Orlando, Florida, United States
Kannarr Eye Care LLC
Pittsburg, Kansas, United States
Distance Visual Acuity (VA) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in 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 inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Time frame: Day 1 and Day 30, each wear period (approximately 30 days)
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Fischer Laser Eye Center
Willmar, Minnesota, United States
SUNY College of Optometry Clinical Vision Research Center
New York, New York, United States
West Bay Eye Associates
Warwick, Rhode Island, United States