This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort, overall opinion and end of day comfort following wear of two different contact lenses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).
Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).
Stam & Associates Eye Care
Jacksonville, Florida, United States
Omega Vision Center
Longwood, Florida, United States
Maitland Vision Center - North Orlando Ave
Maitland, Florida, United States
Long Lasting Comfort
Long lasting comfort, with respect to contact lens wear, was assessed using the individual questionnaire item: 'I could wear these contact lenses comfortably for as long as I wanted to'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Long lasting comfort was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
Time frame: 1-week Follow-up
Overall Opinion
Overall opinion, with respect to the study contact lenses, was evaluated using the individual questionnaire item 'Considering your experience with the study contact lenses, which statement best describes your overall opinion of these contact lenses?'. This item utilized an excellence scale of, 1: Poor, 2: Fair, 3: Good, 4: Very Good and 5: Excellent. Overall opinion was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Excellent or Very good and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
Time frame: 1-Week Follow-up
Comfort at the End of the Day
Comfort at the end of the day, with respect to contact lens wear, was assessed using the individual questionnaire 'These lenses were very comfortable at the end of the day'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Comfort at the end of the day was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
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Kannarr Eye Care - 101 North Broadway
Pittsburg, Kansas, United States
Birmingham Vision Care
Bloomfield Hills, Michigan, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Sacco Eye Group
Vestal, New York, United States
Procare Vision Centers
Granville, Ohio, United States
Professional Vision Care Inc. - Westerville
Westerville, Ohio, United States
Optometry Group, PLLC
Memphis, Tennessee, United States
...and 2 more locations
Time frame: 1-Week Follow-up