Visual Acuity
Conditions
Brief summary
This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.
Interventions
DEVICEACUVUE Oasys 1-Day
TEST
DEVICEPrecision 1
CONTROL
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 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 40 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks. 5. By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week. 6. The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D) must be between -1.00 and -4.00 DS (inclusive) in each eye. 7. The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less. 8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Be currently pregnant or breastfeeding 2. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications. 3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.). 4. Habitually wear monovision, multifocal, toric, or extended wear contact lens correction 5. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment 6. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician) 7. Have a history of amblyopia or strabismus. 8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months. 9. Have clinically significant (Grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 10. Have any ocular infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort (Phase I) | 1-Week Follow-up | Overall Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: Overall Comfort with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| End of Day Comfort (Phase I) | 1-Week Follow-up | End of day Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: comfort at the end of the day with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| End of Day Dryness (Phase I) | 1-Week Follow-up | End of day Dryness was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| End of Day Comfort (Phase II) | 1-Week Follow-up | End of day Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: comfort at the end of the day with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| End of Day Dryness (Phase II) | 1-Week Follow-up | End of day Dryness was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Overall Comfort (Phase II) | 1-Week Follow-up | Overall Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: Overall Comfort with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Insertion (Phase II) | 1-Week Follow-up | Ease of Insertion was assessed using the individual questionnaire item How would you rate the study contact lenses on: Ease of putting the lenses on your eyes with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Comfort Throughout the Day (Phase II) | 1-Week Follow-up | Comfort Throughout the Day was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Ease of Removal (Phase II) | 1-Week Follow-up | Ease of Removal was assessed using the individual questionnaire item how would you rate the study contact lenses on: Ease of taking the lenses off your eyes with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Comfort While Using Digital Devices (Phase II) | 1-Week Follow-up | Comfort while Using Digital Devices was assessed using the individual questionnaire item How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets) with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Dryness While Using Digital Devices (Phase II) | 1-Week Follow-up | Dryness while using Digital Devices was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets). with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Lens Awareness Upon Insertion (Phase II) | 1-Minute Post lens fitting | Lens Awareness Upon Insertion was assessed using the individual questionnaire item I lost awareness of these lenses shortly after inserting them (within one minute) with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies. |
| Comfort Upon Insertion (Phase II) | 1-Minute Post lens fitting | Comfort Upon Insertion was assessed using the individual questionnaire item These lenses were comfortable shortly after inserting them (within one minute) with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies. |
| Overall Ease of Handling (Phase II) | 1-Week Follow-up | Overall Ease of Handling was assessed using the individual questionnaire item How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off). with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
Countries
United States
Participant flow
Recruitment details
This was a 2-Phase study. In Phase I, 75 subjects were enrolled. Of those enrolled into Phase I, all subjects were dispensed at least 1 study lens. Of those dispensed, 72 completed Phase I, while 3 subject discontinued. In Phase II, 227 subjects were enrolled. Of those enrolled, all subjects were dispensed at least 1 study lens. Of those dispensed in Phase II 206 completed the Phase II, while 21 subjects discontinued from Phase II.
Pre-assignment details
Phase I and Phase II are mutually exclusive. Data collected from Phase I was used to estimate the sample size requirements for Phase II primary endpoints.
Participants by arm
| Arm | Count |
|---|---|
| Phase I All subjects that were enrolled into Phase I of the study. | 75 |
| Phase II All subjects that were enrolled in Phase II of the study | 227 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase II- Period 1 | COVID-19 Related | 0 | 0 | 6 | 6 |
| Phase II- Period 1 | Subject enrolled in error | 0 | 0 | 1 | 0 |
| Phase II -Period 2 | COVID-19 related | 0 | 0 | 4 | 3 |
| Phase II -Period 2 | Incorrectly dispensed | 0 | 0 | 0 | 1 |
| Phase I- Period 1 | COVID-19 related | 0 | 1 | 0 | 0 |
| Phase I- Period 1 | Subject enrolled in error | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase I | Phase II | Total |
|---|---|---|---|
| Age, Continuous | 28.4 Years STANDARD_DEVIATION 6.94 | 29.4 Years STANDARD_DEVIATION 6.23 | 29.2 Years STANDARD_DEVIATION 6.42 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 24 Participants | 30 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 63 Participants | 191 Participants | 254 Participants |
| Region of Enrollment United States | 75 Participants | 227 Participants | 302 Participants |
| Sex: Female, Male Female | 50 Participants | 172 Participants | 222 Participants |
| Sex: Female, Male Male | 25 Participants | 55 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 74 | 0 / 221 | 0 / 220 |
| other Total, other adverse events | 0 / 73 | 0 / 74 | 0 / 221 | 0 / 220 |
| serious Total, serious adverse events | 0 / 73 | 0 / 74 | 0 / 221 | 0 / 220 |
Outcome results
Primary
End of Day Comfort (Phase I)
End of day Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: comfort at the end of the day with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | End of Day Comfort (Phase I) | Very Good | 28 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase I) | Fair | 4 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase I) | Good | 9 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase I) | Poor | 2 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase I) | Excellent | 29 Number of responses |
| Verofilcon A | End of Day Comfort (Phase I) | Poor | 4 Number of responses |
| Verofilcon A | End of Day Comfort (Phase I) | Excellent | 25 Number of responses |
| Verofilcon A | End of Day Comfort (Phase I) | Very Good | 17 Number of responses |
| Verofilcon A | End of Day Comfort (Phase I) | Good | 16 Number of responses |
| Verofilcon A | End of Day Comfort (Phase I) | Fair | 10 Number of responses |
Comparison: Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.95% CI: [1.16, 10.16]Generalized linear Mixed Model Analysis
Primary
End of Day Comfort (Phase II)
End of day Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: comfort at the end of the day with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | End of Day Comfort (Phase II) | Very Good | 63 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase II) | Fair | 26 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase II) | Good | 24 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase II) | Poor | 8 Number of responses |
| Senofilcon A (C3) | End of Day Comfort (Phase II) | Excellent | 89 Number of responses |
| Verofilcon A | End of Day Comfort (Phase II) | Poor | 13 Number of responses |
| Verofilcon A | End of Day Comfort (Phase II) | Excellent | 65 Number of responses |
| Verofilcon A | End of Day Comfort (Phase II) | Very Good | 59 Number of responses |
| Verofilcon A | End of Day Comfort (Phase II) | Good | 39 Number of responses |
| Verofilcon A | End of Day Comfort (Phase II) | Fair | 34 Number of responses |
Comparison: It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.98.33% CI: [1.09, 2.83]Generalized linear Mixed Model Analysis
Primary
End of Day Dryness (Phase I)
End of day Dryness was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | End of Day Dryness (Phase I) | Very Good | 28 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase I) | Fair | 6 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase I) | Good | 9 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase I) | Poor | 3 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase I) | Excellent | 26 Number of responses |
| Verofilcon A | End of Day Dryness (Phase I) | Poor | 6 Number of responses |
| Verofilcon A | End of Day Dryness (Phase I) | Excellent | 22 Number of responses |
| Verofilcon A | End of Day Dryness (Phase I) | Very Good | 20 Number of responses |
| Verofilcon A | End of Day Dryness (Phase I) | Good | 12 Number of responses |
| Verofilcon A | End of Day Dryness (Phase I) | Fair | 12 Number of responses |
Comparison: Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.95% CI: [1.05, 6.76]Generalized linear Mixed Model Analysis
Primary
End of Day Dryness (Phase II)
End of day Dryness was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | End of Day Dryness (Phase II) | Very Good | 55 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase II) | Fair | 32 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase II) | Good | 27 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase II) | Poor | 13 Number of responses |
| Senofilcon A (C3) | End of Day Dryness (Phase II) | Excellent | 83 Number of responses |
| Verofilcon A | End of Day Dryness (Phase II) | Poor | 20 Number of responses |
| Verofilcon A | End of Day Dryness (Phase II) | Excellent | 53 Number of responses |
| Verofilcon A | End of Day Dryness (Phase II) | Very Good | 64 Number of responses |
| Verofilcon A | End of Day Dryness (Phase II) | Good | 32 Number of responses |
| Verofilcon A | End of Day Dryness (Phase II) | Fair | 41 Number of responses |
Comparison: It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.96.66% CI: [1.02, 2.28]Generalized linear Mixed Model Analysis
Primary
Overall Comfort (Phase I)
Overall Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: Overall Comfort with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Overall Comfort (Phase I) | Very Good | 20 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase I) | Fair | 2 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase I) | Good | 5 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase I) | Poor | 0 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase I) | Excellent | 45 Number of responses |
| Verofilcon A | Overall Comfort (Phase I) | Poor | 1 Number of responses |
| Verofilcon A | Overall Comfort (Phase I) | Excellent | 32 Number of responses |
| Verofilcon A | Overall Comfort (Phase I) | Very Good | 23 Number of responses |
| Verofilcon A | Overall Comfort (Phase I) | Good | 9 Number of responses |
| Verofilcon A | Overall Comfort (Phase I) | Fair | 7 Number of responses |
Comparison: Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.95% CI: [0.8, 22.54]Generalized linear Mixed Model Analysis
Primary
Overall Comfort (Phase II)
Overall Comfort was assessed using the individual questionnaire item How would you rate the study contact lenses on: Overall Comfort with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Overall Comfort (Phase II) | Excellent | 127 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase II) | Very Good | 44 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase II) | Good | 28 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase II) | Fair | 11 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase II) | Poor | 0 Number of responses |
| Senofilcon A (C3) | Overall Comfort (Phase II) | Not Applicable | 0 Number of responses |
| Verofilcon A | Overall Comfort (Phase II) | Poor | 3 Number of responses |
| Verofilcon A | Overall Comfort (Phase II) | Excellent | 104 Number of responses |
| Verofilcon A | Overall Comfort (Phase II) | Fair | 13 Number of responses |
| Verofilcon A | Overall Comfort (Phase II) | Very Good | 59 Number of responses |
| Verofilcon A | Overall Comfort (Phase II) | Not Applicable | 1 Number of responses |
| Verofilcon A | Overall Comfort (Phase II) | Good | 30 Number of responses |
Comparison: It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.95% CI: [0.77, 2.03]Generalized linear Mixed Model Analysis
Secondary
Comfort Throughout the Day (Phase II)
Comfort Throughout the Day was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Comfort Throughout the Day (Phase II) | Very Good | 55 Number of responses |
| Senofilcon A (C3) | Comfort Throughout the Day (Phase II) | Fair | 26 Number of responses |
| Senofilcon A (C3) | Comfort Throughout the Day (Phase II) | Good | 29 Number of responses |
| Senofilcon A (C3) | Comfort Throughout the Day (Phase II) | Poor | 4 Number of responses |
| Senofilcon A (C3) | Comfort Throughout the Day (Phase II) | Excellent | 96 Number of responses |
| Verofilcon A | Comfort Throughout the Day (Phase II) | Poor | 8 Number of responses |
| Verofilcon A | Comfort Throughout the Day (Phase II) | Excellent | 76 Number of responses |
| Verofilcon A | Comfort Throughout the Day (Phase II) | Very Good | 56 Number of responses |
| Verofilcon A | Comfort Throughout the Day (Phase II) | Good | 45 Number of responses |
| Verofilcon A | Comfort Throughout the Day (Phase II) | Fair | 25 Number of responses |
Secondary
Comfort Upon Insertion (Phase II)
Comfort Upon Insertion was assessed using the individual questionnaire item These lenses were comfortable shortly after inserting them (within one minute) with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
Time frame: 1-Minute Post lens fitting
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Comfort Upon Insertion (Phase II) | Disagree | 0 Number of responses |
| Senofilcon A (C3) | Comfort Upon Insertion (Phase II) | Agree | 61 Number of responses |
| Senofilcon A (C3) | Comfort Upon Insertion (Phase II) | Neither Agree nor Disagree | 4 Number of responses |
| Senofilcon A (C3) | Comfort Upon Insertion (Phase II) | Strongly Agree | 153 Number of responses |
| Senofilcon A (C3) | Comfort Upon Insertion (Phase II) | Strongly Disagree | 2 Number of responses |
| Verofilcon A | Comfort Upon Insertion (Phase II) | Strongly Agree | 139 Number of responses |
| Verofilcon A | Comfort Upon Insertion (Phase II) | Strongly Disagree | 6 Number of responses |
| Verofilcon A | Comfort Upon Insertion (Phase II) | Disagree | 3 Number of responses |
| Verofilcon A | Comfort Upon Insertion (Phase II) | Neither Agree nor Disagree | 9 Number of responses |
| Verofilcon A | Comfort Upon Insertion (Phase II) | Agree | 64 Number of responses |
Secondary
Comfort While Using Digital Devices (Phase II)
Comfort while Using Digital Devices was assessed using the individual questionnaire item How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets) with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Comfort While Using Digital Devices (Phase II) | Not Applicable | 1 Number of responses |
| Senofilcon A (C3) | Comfort While Using Digital Devices (Phase II) | Excellent | 111 Number of responses |
| Senofilcon A (C3) | Comfort While Using Digital Devices (Phase II) | Very Good | 46 Number of responses |
| Senofilcon A (C3) | Comfort While Using Digital Devices (Phase II) | Good | 33 Number of responses |
| Senofilcon A (C3) | Comfort While Using Digital Devices (Phase II) | Fair | 17 Number of responses |
| Senofilcon A (C3) | Comfort While Using Digital Devices (Phase II) | Poor | 2 Number of responses |
| Verofilcon A | Comfort While Using Digital Devices (Phase II) | Fair | 22 Number of responses |
| Verofilcon A | Comfort While Using Digital Devices (Phase II) | Not Applicable | 2 Number of responses |
| Verofilcon A | Comfort While Using Digital Devices (Phase II) | Good | 31 Number of responses |
| Verofilcon A | Comfort While Using Digital Devices (Phase II) | Excellent | 90 Number of responses |
| Verofilcon A | Comfort While Using Digital Devices (Phase II) | Poor | 4 Number of responses |
| Verofilcon A | Comfort While Using Digital Devices (Phase II) | Very Good | 61 Number of responses |
Secondary
Dryness While Using Digital Devices (Phase II)
Dryness while using Digital Devices was assessed using the individual questionnaire item How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets). with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Dryness While Using Digital Devices (Phase II) | Not Applicable | 0 Number of responses |
| Senofilcon A (C3) | Dryness While Using Digital Devices (Phase II) | Excellent | 102 Number of responses |
| Senofilcon A (C3) | Dryness While Using Digital Devices (Phase II) | Very Good | 55 Number of responses |
| Senofilcon A (C3) | Dryness While Using Digital Devices (Phase II) | Good | 25 Number of responses |
| Senofilcon A (C3) | Dryness While Using Digital Devices (Phase II) | Fair | 22 Number of responses |
| Senofilcon A (C3) | Dryness While Using Digital Devices (Phase II) | Poor | 6 Number of responses |
| Verofilcon A | Dryness While Using Digital Devices (Phase II) | Fair | 31 Number of responses |
| Verofilcon A | Dryness While Using Digital Devices (Phase II) | Not Applicable | 2 Number of responses |
| Verofilcon A | Dryness While Using Digital Devices (Phase II) | Good | 31 Number of responses |
| Verofilcon A | Dryness While Using Digital Devices (Phase II) | Excellent | 79 Number of responses |
| Verofilcon A | Dryness While Using Digital Devices (Phase II) | Poor | 4 Number of responses |
| Verofilcon A | Dryness While Using Digital Devices (Phase II) | Very Good | 63 Number of responses |
Secondary
Ease of Insertion (Phase II)
Ease of Insertion was assessed using the individual questionnaire item How would you rate the study contact lenses on: Ease of putting the lenses on your eyes with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Ease of Insertion (Phase II) | Not Applicable | 0 Number of responses |
| Senofilcon A (C3) | Ease of Insertion (Phase II) | Excellent | 145 Number of responses |
| Senofilcon A (C3) | Ease of Insertion (Phase II) | Very Good | 39 Number of responses |
| Senofilcon A (C3) | Ease of Insertion (Phase II) | Good | 20 Number of responses |
| Senofilcon A (C3) | Ease of Insertion (Phase II) | Fair | 6 Number of responses |
| Senofilcon A (C3) | Ease of Insertion (Phase II) | Poor | 0 Number of responses |
| Verofilcon A | Ease of Insertion (Phase II) | Fair | 8 Number of responses |
| Verofilcon A | Ease of Insertion (Phase II) | Not Applicable | 2 Number of responses |
| Verofilcon A | Ease of Insertion (Phase II) | Good | 26 Number of responses |
| Verofilcon A | Ease of Insertion (Phase II) | Excellent | 136 Number of responses |
| Verofilcon A | Ease of Insertion (Phase II) | Poor | 2 Number of responses |
| Verofilcon A | Ease of Insertion (Phase II) | Very Good | 36 Number of responses |
Secondary
Ease of Removal (Phase II)
Ease of Removal was assessed using the individual questionnaire item how would you rate the study contact lenses on: Ease of taking the lenses off your eyes with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Ease of Removal (Phase II) | Not Applicable | 0 Number of responses |
| Senofilcon A (C3) | Ease of Removal (Phase II) | Excellent | 139 Number of responses |
| Senofilcon A (C3) | Ease of Removal (Phase II) | Very Good | 37 Number of responses |
| Senofilcon A (C3) | Ease of Removal (Phase II) | Good | 22 Number of responses |
| Senofilcon A (C3) | Ease of Removal (Phase II) | Fair | 11 Number of responses |
| Senofilcon A (C3) | Ease of Removal (Phase II) | Poor | 1 Number of responses |
| Verofilcon A | Ease of Removal (Phase II) | Fair | 21 Number of responses |
| Verofilcon A | Ease of Removal (Phase II) | Not Applicable | 3 Number of responses |
| Verofilcon A | Ease of Removal (Phase II) | Good | 30 Number of responses |
| Verofilcon A | Ease of Removal (Phase II) | Excellent | 100 Number of responses |
| Verofilcon A | Ease of Removal (Phase II) | Poor | 15 Number of responses |
| Verofilcon A | Ease of Removal (Phase II) | Very Good | 41 Number of responses |
Secondary
Lens Awareness Upon Insertion (Phase II)
Lens Awareness Upon Insertion was assessed using the individual questionnaire item I lost awareness of these lenses shortly after inserting them (within one minute) with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
Time frame: 1-Minute Post lens fitting
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Lens Awareness Upon Insertion (Phase II) | Disagree | 6 Number of responses |
| Senofilcon A (C3) | Lens Awareness Upon Insertion (Phase II) | Agree | 65 Number of responses |
| Senofilcon A (C3) | Lens Awareness Upon Insertion (Phase II) | Neither Agree nor Disagree | 7 Number of responses |
| Senofilcon A (C3) | Lens Awareness Upon Insertion (Phase II) | Strongly Agree | 126 Number of responses |
| Senofilcon A (C3) | Lens Awareness Upon Insertion (Phase II) | Strongly Disagree | 16 Number of responses |
| Verofilcon A | Lens Awareness Upon Insertion (Phase II) | Strongly Agree | 113 Number of responses |
| Verofilcon A | Lens Awareness Upon Insertion (Phase II) | Strongly Disagree | 16 Number of responses |
| Verofilcon A | Lens Awareness Upon Insertion (Phase II) | Disagree | 13 Number of responses |
| Verofilcon A | Lens Awareness Upon Insertion (Phase II) | Neither Agree nor Disagree | 8 Number of responses |
| Verofilcon A | Lens Awareness Upon Insertion (Phase II) | Agree | 71 Number of responses |
Secondary
Overall Ease of Handling (Phase II)
Overall Ease of Handling was assessed using the individual questionnaire item How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off). with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Time frame: 1-Week Follow-up
Population: All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A (C3) | Overall Ease of Handling (Phase II) | Not Applicable | 0 Number of responses |
| Senofilcon A (C3) | Overall Ease of Handling (Phase II) | Excellent | 140 Number of responses |
| Senofilcon A (C3) | Overall Ease of Handling (Phase II) | Very Good | 36 Number of responses |
| Senofilcon A (C3) | Overall Ease of Handling (Phase II) | Good | 23 Number of responses |
| Senofilcon A (C3) | Overall Ease of Handling (Phase II) | Fair | 11 Number of responses |
| Senofilcon A (C3) | Overall Ease of Handling (Phase II) | Poor | 0 Number of responses |
| Verofilcon A | Overall Ease of Handling (Phase II) | Fair | 16 Number of responses |
| Verofilcon A | Overall Ease of Handling (Phase II) | Not Applicable | 2 Number of responses |
| Verofilcon A | Overall Ease of Handling (Phase II) | Good | 32 Number of responses |
| Verofilcon A | Overall Ease of Handling (Phase II) | Excellent | 112 Number of responses |
| Verofilcon A | Overall Ease of Handling (Phase II) | Poor | 8 Number of responses |
| Verofilcon A | Overall Ease of Handling (Phase II) | Very Good | 40 Number of responses |