Trial Outcomes & Findings for Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear (NCT NCT06749496)
NCT ID: NCT06749496
Last Updated: 2026-05-22
Results Overview
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.
COMPLETED
NA
134 participants
1-week Follow-up
2026-05-22
Participant Flow
A total of 134 subjects were enrolled in this study. Of those enrolled, 133 enrolled subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, all 133 subjects completed the study.
Participant milestones
| Measure |
Test (Senofilcon A)/Control (Delefilcon A)
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
|
Control (Delefilcon A)/Test (Senofilcon A)
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
|
|---|---|---|
|
Period 1
STARTED
|
63
|
70
|
|
Period 1
COMPLETED
|
63
|
70
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
63
|
70
|
|
Period 2
COMPLETED
|
63
|
70
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
Baseline characteristics by cohort
| Measure |
Overall Reporting Group
n=133 Participants
All subjects dispensed at least one study contact lens.
|
|---|---|
|
Age, Continuous
|
30.4 Years
STANDARD_DEVIATION 5.79 • n=2 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
133 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 1-week Follow-upPopulation: All subjects dispensed at least one study lens. Subjects were analyzed as per planned randomized treatment.
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.
Outcome measures
| Measure |
Test (Senofilcon)
n=133 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Delefilcon A)
n=133 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Long Lasting Comfort
Strongly Agree or Agree (Y=1)
|
100 Participants
|
62 Participants
|
|
Long Lasting Comfort
Strongly Disagree, Disagree or Neither Agree nor Disagree (Y=0)
|
33 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-upOverall 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.
Outcome measures
| Measure |
Test (Senofilcon)
n=133 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Delefilcon A)
n=133 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall Opinion
Excellent or Very Good (Y=1)
|
96 Participants
|
52 Participants
|
|
Overall Opinion
Good, Fair or Poor (Y=0)
|
37 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-upComfort 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.
Outcome measures
| Measure |
Test (Senofilcon)
n=133 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Delefilcon A)
n=133 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Comfort at the End of the Day
Strongly Agree or Agree (Y=1)
|
97 Participants
|
60 Participants
|
|
Comfort at the End of the Day
Strongly Disagree, Disagree or Neither Agree nor Disagree (Y=0)
|
36 Participants
|
73 Participants
|
Adverse Events
Test (Senofilcon A)
Control (Delefilcon A)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place