This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.
Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Each subject randomized to wear either the test or control in either the left of right eye.
Each subject randomized to wear either the test or control in either the left of right eye.
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Subjective Ratings of Comfort
Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: Baseline (After 10 minutes of lens dispense)
Subjective Ratings of Comfort
Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: 2 weeks
Subjective Ratings of Comfort
Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: 4 weeks
Subjective Comfort Preference
Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time frame: Baseline (after 10 minutes of lens dispense)
Subjective Comfort Preference
Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time frame: 2 weeks
Subjective Comfort Preference
Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time frame: 4 weeks
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: Baseline (After 10 minutes of lens dispense)
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Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: 2 weeks
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: 4 weeks