Trial Outcomes & Findings for Clinical Performance of Senofilcon A Investigational Lens (NCT NCT05300763)
NCT ID: NCT05300763
Last Updated: 2023-06-22
Results Overview
End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.
COMPLETED
NA
344 participants
2-Week Follow-up
2023-06-22
Participant Flow
A total of 344 subjects were enrolled in this study. Of those enrolled, 342 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 339 subjects completed the study while 3 subjects were discontinued.
Participant milestones
| Measure |
Test (Senofilcon A C3)
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
Subjects randomized to receive the Control lens during the study
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
171
|
|
Overall Study
COMPLETED
|
169
|
170
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Test (Senofilcon A C3)
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
Subjects randomized to receive the Control lens during the study
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Major Protocol Deviation
|
1
|
0
|
|
Overall Study
Subject No Longer Meets Eligibility Criteria
|
1
|
0
|
Baseline Characteristics
Clinical Performance of Senofilcon A Investigational Lens
Baseline characteristics by cohort
| Measure |
Test (Senofilcon A C3)
n=171 Participants
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
n=171 Participants
Subjects that wore the Control lens during the study.
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 5.44 • n=99 Participants
|
30.0 Years
STANDARD_DEVIATION 5.63 • n=107 Participants
|
29.7 Years
STANDARD_DEVIATION 5.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
234 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
141 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
286 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
171 Participants
n=99 Participants
|
171 Participants
n=107 Participants
|
342 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=170 Participants
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
n=170 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
End of Day Comfort
Very Satisfied
|
76 Number of responses
|
46 Number of responses
|
|
End of Day Comfort
Satisfied
|
52 Number of responses
|
58 Number of responses
|
|
End of Day Comfort
Neither Satisfied nor Dissatisfied
|
16 Number of responses
|
21 Number of responses
|
|
End of Day Comfort
Dissatisfied
|
18 Number of responses
|
35 Number of responses
|
|
End of Day Comfort
Very Dissatisfied
|
8 Number of responses
|
10 Number of responses
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
Lens performance in digital device use was assessed using an individual item "Reduction in the feeling of tired eyes from using a computer or other digital device". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=170 Participants
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
n=170 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Digital Device Use
Not Applicable
|
2 Number of responses
|
9 Number of responses
|
|
Digital Device Use
Excellent
|
65 Number of responses
|
47 Number of responses
|
|
Digital Device Use
Very Good
|
68 Number of responses
|
59 Number of responses
|
|
Digital Device Use
Good
|
17 Number of responses
|
26 Number of responses
|
|
Digital Device Use
Fair
|
12 Number of responses
|
23 Number of responses
|
|
Digital Device Use
Poor
|
6 Number of responses
|
6 Number of responses
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
Comfort throughout the day was measured using an individual item "I could wear these contact lenses comfortably for as long as I wanted to". Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=170 Participants
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
n=170 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Comfort Throughout the Day
Agree
|
43 Number of responses
|
43 Number of responses
|
|
Comfort Throughout the Day
Strongly Disagree
|
12 Number of responses
|
18 Number of responses
|
|
Comfort Throughout the Day
Disagree
|
26 Number of responses
|
48 Number of responses
|
|
Comfort Throughout the Day
Neither Agree Nor Disagree
|
16 Number of responses
|
17 Number of responses
|
|
Comfort Throughout the Day
Strongly Agree
|
73 Number of responses
|
44 Number of responses
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
Comfortable vision while night driving was assessed using an individual item "Ability to see comfortably while driving at night". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=170 Participants
Subjects randomized to receive the Test lens during the study
|
Control (Delefilcon A)
n=170 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Comfortable Vision While Night Driving
Not Applicable
|
2 Number of responses
|
3 Number of responses
|
|
Comfortable Vision While Night Driving
Excellent
|
91 Number of responses
|
65 Number of responses
|
|
Comfortable Vision While Night Driving
Very Good
|
47 Number of responses
|
57 Number of responses
|
|
Comfortable Vision While Night Driving
Good
|
25 Number of responses
|
34 Number of responses
|
|
Comfortable Vision While Night Driving
Fair
|
3 Number of responses
|
9 Number of responses
|
|
Comfortable Vision While Night Driving
Poor
|
2 Number of responses
|
2 Number of responses
|
Adverse Events
Test (Senofilcon A C3)
Control (Delefilcon A)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John R. Buch, Senior Principal Research Optometrist
Johnson & Johnson Vision Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60