The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits. Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Investigational soft contact lenses for daily wear worn in Part A of the study
Commercially available soft contact lenses for daily wear worn in Part A of the study
Commercially available soft contact lenses for daily wear worn in Part B of the study
Alcon Investigator 6356
Longwood, Florida, United States
Alcon Investigator 6565
Maitland, Florida, United States
Alcon Investigator 6401
Warwick, Rhode Island, United States
Alcon Investigator 6353
Memphis, Tennessee, United States
Distance Visual Acuity (VA) (Part A)
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Time frame: Day 30, each study lens type
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For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study