The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.
Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Commercially marketed silicone hydrogel contact lens
Commercially marketed, hydrogen peroxide-based contact lens care system
University of Waterloo
Waterloo, Ontario, Canada
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 1
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 1
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 1
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 15
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
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Time frame: Day 15
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 15
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 43
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 43
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Time frame: Day 43