Visual Acuity
Conditions
Brief summary
This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.
Interventions
DEVICEsenofilcon A prototype
Test
DEVICEDailies Total 1
Control
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 39 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily wear or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. 5. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study. 6. Possess a wearable pair of spectacles that provide correction for distance vision. Inclusion Criteria at Baseline Evaluation 7. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye. 8. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye. 9. The best corrected, monocular, distance visual acuity must be 20/25or better in each eye.
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of Day Comfort | 2-Week Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digital Device Use | 2-Week Follow-up | 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. |
| Comfort Throughout the Day | 2-Week Follow-up | 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. |
| Comfortable Vision While Night Driving | 2-Week Follow-up | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Test (Senofilcon A C3) Subjects randomized to receive the Test lens during the study | 171 |
| Control (Delefilcon A) Subjects that wore the Control lens during the study. | 171 |
| Total | 342 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Control (Delefilcon A) | Total | Test (Senofilcon A C3) |
|---|---|---|---|
| Age, Continuous | 30.0 Years STANDARD_DEVIATION 5.63 | 29.7 Years STANDARD_DEVIATION 5.53 | 29.5 Years STANDARD_DEVIATION 5.44 |
| Race/Ethnicity, Customized Asian | 8 Participants | 20 Participants | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants | 30 Participants | 15 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 145 Participants | 286 Participants | 141 Participants |
| Region of Enrollment United States | 171 Participants | 342 Participants | 171 Participants |
| Sex: Female, Male Female | 117 Participants | 234 Participants | 117 Participants |
| Sex: Female, Male Male | 54 Participants | 108 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 171 | 0 / 171 |
| other Total, other adverse events | 0 / 171 | 0 / 171 |
| serious Total, serious adverse events | 0 / 171 | 0 / 171 |
Outcome results
Primary
End of Day Comfort
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.
Time frame: 2-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (Senofilcon A C3) | End of Day Comfort | Satisfied | 52 Number of responses |
| Test (Senofilcon A C3) | End of Day Comfort | Dissatisfied | 18 Number of responses |
| Test (Senofilcon A C3) | End of Day Comfort | Neither Satisfied nor Dissatisfied | 16 Number of responses |
| Test (Senofilcon A C3) | End of Day Comfort | Very Dissatisfied | 8 Number of responses |
| Test (Senofilcon A C3) | End of Day Comfort | Very Satisfied | 76 Number of responses |
| Control (Delefilcon A) | End of Day Comfort | Very Dissatisfied | 10 Number of responses |
| Control (Delefilcon A) | End of Day Comfort | Very Satisfied | 46 Number of responses |
| Control (Delefilcon A) | End of Day Comfort | Satisfied | 58 Number of responses |
| Control (Delefilcon A) | End of Day Comfort | Neither Satisfied nor Dissatisfied | 21 Number of responses |
| Control (Delefilcon A) | End of Day Comfort | Dissatisfied | 35 Number of responses |
95% CI: [1.25, 3.22]Linear Mixed Model
Secondary
Comfortable Vision While Night Driving
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.
Time frame: 2-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (Senofilcon A C3) | Comfortable Vision While Night Driving | Good | 25 Number of responses |
| Test (Senofilcon A C3) | Comfortable Vision While Night Driving | Excellent | 91 Number of responses |
| Test (Senofilcon A C3) | Comfortable Vision While Night Driving | Poor | 2 Number of responses |
| Test (Senofilcon A C3) | Comfortable Vision While Night Driving | Fair | 3 Number of responses |
| Test (Senofilcon A C3) | Comfortable Vision While Night Driving | Not Applicable | 2 Number of responses |
| Test (Senofilcon A C3) | Comfortable Vision While Night Driving | Very Good | 47 Number of responses |
| Control (Delefilcon A) | Comfortable Vision While Night Driving | Poor | 2 Number of responses |
| Control (Delefilcon A) | Comfortable Vision While Night Driving | Very Good | 57 Number of responses |
| Control (Delefilcon A) | Comfortable Vision While Night Driving | Good | 34 Number of responses |
| Control (Delefilcon A) | Comfortable Vision While Night Driving | Not Applicable | 3 Number of responses |
| Control (Delefilcon A) | Comfortable Vision While Night Driving | Excellent | 65 Number of responses |
| Control (Delefilcon A) | Comfortable Vision While Night Driving | Fair | 9 Number of responses |
95% CI: [1.04, 3.02]Linear Mixed Model
Secondary
Comfort Throughout the Day
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.
Time frame: 2-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (Senofilcon A C3) | Comfort Throughout the Day | Disagree | 26 Number of responses |
| Test (Senofilcon A C3) | Comfort Throughout the Day | Agree | 43 Number of responses |
| Test (Senofilcon A C3) | Comfort Throughout the Day | Strongly Disagree | 12 Number of responses |
| Test (Senofilcon A C3) | Comfort Throughout the Day | Strongly Agree | 73 Number of responses |
| Test (Senofilcon A C3) | Comfort Throughout the Day | Neither Agree Nor Disagree | 16 Number of responses |
| Control (Delefilcon A) | Comfort Throughout the Day | Strongly Agree | 44 Number of responses |
| Control (Delefilcon A) | Comfort Throughout the Day | Neither Agree Nor Disagree | 17 Number of responses |
| Control (Delefilcon A) | Comfort Throughout the Day | Strongly Disagree | 18 Number of responses |
| Control (Delefilcon A) | Comfort Throughout the Day | Agree | 43 Number of responses |
| Control (Delefilcon A) | Comfort Throughout the Day | Disagree | 48 Number of responses |
97.5% CI: [1.3, 3.64]Linear Mixed Model
Secondary
Digital Device Use
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.
Time frame: 2-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (Senofilcon A C3) | Digital Device Use | Good | 17 Number of responses |
| Test (Senofilcon A C3) | Digital Device Use | Excellent | 65 Number of responses |
| Test (Senofilcon A C3) | Digital Device Use | Fair | 12 Number of responses |
| Test (Senofilcon A C3) | Digital Device Use | Very Good | 68 Number of responses |
| Test (Senofilcon A C3) | Digital Device Use | Poor | 6 Number of responses |
| Test (Senofilcon A C3) | Digital Device Use | Not Applicable | 2 Number of responses |
| Control (Delefilcon A) | Digital Device Use | Poor | 6 Number of responses |
| Control (Delefilcon A) | Digital Device Use | Excellent | 47 Number of responses |
| Control (Delefilcon A) | Digital Device Use | Very Good | 59 Number of responses |
| Control (Delefilcon A) | Digital Device Use | Good | 26 Number of responses |
| Control (Delefilcon A) | Digital Device Use | Fair | 23 Number of responses |
| Control (Delefilcon A) | Digital Device Use | Not Applicable | 9 Number of responses |
96.25% CI: [1.18, 3.41]Linear Mixed Model