The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
41
galyfilcon A Plus, BC: 8.3 or 8.7
senofilcon A, BC:8.4 or 8.8
galyfilcon A , BC: 8.3 or 8.7
Unnamed facility
Farnham, Surrey, United Kingdom
Unnamed facility
Birmingham, United Kingdom
Lens Centration Acceptance
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Time frame: after 15 minutes of contact lens wear
Primary Gaze Lens Movement
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Time frame: after 15 minutes of contact lens wear
Fit Acceptability
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Time frame: after 15 minutes of contact lens wear
New Lens Power Fit Match to Control Lenses
The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.
Time frame: after 15 minutes of contact lens wear
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