Trial Outcomes & Findings for Clinical Evaluation of Approved Contact Lenses (NCT NCT02699593)
NCT ID: NCT02699593
Last Updated: 2017-07-12
Results Overview
Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.
COMPLETED
NA
142 participants
2-week follow-up
2017-07-12
Participant Flow
A total of 142 subjects were enrolled into this study. Of the enrolled 1 subject did not meet the eligibility criteria and 141 were dispensed a study lens. Of the dispensed subjects 125 completed the study and 16 subjects were discontinued.
Participant milestones
| Measure |
Senofilcon A(Test)/Senofilcon A(Control)
Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.
|
Senofilcon A(Control)/Senofilcon A(Test)
Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.
|
|---|---|---|
|
Period 1
STARTED
|
72
|
69
|
|
Period 1
COMPLETED
|
67
|
62
|
|
Period 1
NOT COMPLETED
|
5
|
7
|
|
Period 2
STARTED
|
67
|
62
|
|
Period 2
COMPLETED
|
65
|
60
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Senofilcon A(Test)/Senofilcon A(Control)
Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.
|
Senofilcon A(Control)/Senofilcon A(Test)
Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.
|
|---|---|---|
|
Period 1
Unsatisfactory Visual Response
|
0
|
1
|
|
Period 1
Torn Contact Len
|
4
|
3
|
|
Period 1
Protocol Violation
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 1
Adverse Event
|
1
|
1
|
|
Period 2
Adverse Event
|
1
|
1
|
|
Period 2
Lost Contact Lens
|
0
|
1
|
|
Period 2
Torn Contact Lens
|
1
|
0
|
Baseline Characteristics
Clinical Evaluation of Approved Contact Lenses
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=141 Participants
All subjects that were dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
|
31.0 Years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
141 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-week follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.
Outcome measures
| Measure |
Senofilcon A (Test)
n=118 Participants
Subjects that wore the test lens senofilcon A during either the first or second period of the study.
|
Senofilcon A (Control)
n=118 Participants
Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
|
|---|---|---|
|
Contact Lens Wearing Time
|
14.55 Hours
Standard Deviation 1.534
|
14.63 Hours
Standard Deviation 1.516
|
PRIMARY outcome
Timeframe: 2-week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.
Outcome measures
| Measure |
Senofilcon A (Test)
n=236 Eyes
Subjects that wore the test lens senofilcon A during either the first or second period of the study.
|
Senofilcon A (Control)
n=236 Eyes
Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
|
|---|---|---|
|
Visual Acuity (LogMAR)
Bright Low Contrast
|
0.121 LogMAR
Standard Deviation 0.0905
|
0.122 LogMAR
Standard Deviation 0.0881
|
|
Visual Acuity (LogMAR)
Dim High Contrast
|
0.086 LogMAR
Standard Deviation 0.0874
|
0.089 LogMAR
Standard Deviation 0.0846
|
Adverse Events
Senofilcon A (Test)
Senofilcon A (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall, OD, MS, FAAO -Sr. 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