The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.
After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
84
Contact lenses worn during Period 1 or 2, as randomized
Contact lenses worn during Period 1 or 2, as randomized
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time frame: Day 10 ± 3 days, each product
Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time frame: Day 10 ± 3 days, each product
Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.
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Time frame: Day 10 ± 3 days, each product
Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.
Time frame: Day 10 ± 3 days, each product