Trial Outcomes & Findings for Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology (NCT NCT04531241)
NCT ID: NCT04531241
Last Updated: 2021-12-14
Results Overview
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
COMPLETED
NA
136 participants
1-Week Follow-up
2021-12-14
Participant Flow
A total of 136 subjects were enrolled in this study. Of those enrolled, 135 were dispensed at least one study lens while, 1 subject failed to meet all eligibility criteria. Of those subjects dispensed a study lens, 127 completed the study while, 8 subjects were discontinued from the study.
Participant milestones
| Measure |
Senofilcon A (Test)/ Senofilcon A (Control)
subjects that wore the senofilcon A (Test) lens in period 1 and the senofilcon A (Control) in period 2.
|
Senofilcon A (Control)/ Senofilcon A (Test)
subjects that wore the senofilcon A (Control) lens in period 1 and the senofilcon A (Test) in period 2.
|
|---|---|---|
|
Period 1
STARTED
|
68
|
67
|
|
Period 1
COMPLETED
|
64
|
65
|
|
Period 1
NOT COMPLETED
|
4
|
2
|
|
Period 2
STARTED
|
64
|
65
|
|
Period 2
COMPLETED
|
63
|
64
|
|
Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Senofilcon A (Test)/ Senofilcon A (Control)
subjects that wore the senofilcon A (Test) lens in period 1 and the senofilcon A (Control) in period 2.
|
Senofilcon A (Control)/ Senofilcon A (Test)
subjects that wore the senofilcon A (Control) lens in period 1 and the senofilcon A (Test) in period 2.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
2
|
0
|
|
Period 1
Dispesed incorrect lens power
|
1
|
0
|
|
Period 1
Protocol Violation
|
1
|
0
|
|
Period 1
No longer eligible
|
0
|
1
|
|
Period 1
Lens Discomfort
|
0
|
1
|
|
Period 2
Covid-19 Related
|
1
|
1
|
Baseline Characteristics
Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=135 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
128 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
135 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Senofilcon A (Test)
n=108 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Senofilcon A (Control)
n=108 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall CLUE Comfort
|
60.9 unit on a scale
Standard Deviation 22.67
|
65.1 unit on a scale
Standard Deviation 21.47
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Senofilcon A (Test)
n=108 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Senofilcon A (Control)
n=108 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall CLUE Vision
|
65.5 unit on a scale
Standard Deviation 19.31
|
67.8 unit on a scale
Standard Deviation 17.79
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under both high luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For high illumination, the room was required to be \>400 lux with low contrast charts. For low illumination, the room was required to be \<2.5 lux. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Outcome measures
| Measure |
Senofilcon A (Test)
n=108 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Senofilcon A (Control)
n=108 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Visual Performance
Under Low Luminance High Contrast Condition
|
0.02 logMAR
Standard Deviation 0.092
|
0.03 logMAR
Standard Deviation 0.094
|
|
Visual Performance
Under High Luminance Low Contrast Condition
|
0.02 logMAR
Standard Deviation 0.101
|
0.03 logMAR
Standard Deviation 0.093
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow up evaluation.
Outcome measures
| Measure |
Senofilcon A (Test)
n=108 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Senofilcon A (Control)
n=108 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Average Daily Wear Time (in Hours)
|
14.3 hours
Standard Deviation 1.93
|
14.4 hours
Standard Deviation 1.90
|
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
Meredith Bishop, OD, MS, FAAO
Johnson & Johnson Vision Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60