Visual Acuity
Conditions
Brief summary
This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.
Interventions
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be between 18 to 40 years of age at the time of consent. 4. The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye. 5. The subject's refractive cylinder must be ≤1.00D in each eye. 6. The subject must have best corrected visual acuity of 20/30 or better in each eye. 7. The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes. 8. The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week. 9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution. 5. Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction. 6. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. 7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) 8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 9. Any ocular infection. 10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. 12. History of binocular vision abnormality or strabismus. 13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report). 14. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Making Your Eyes Feel Moist Throughout the Day Individual Item | Up to 1 month Follow-up | Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here. |
| Comfort Each and Everyday Individual Item | 1 month Follow-up | Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here. |
| Frequency of Lens Awareness Individual Item | 1 month Follow-up | Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here. |
| Frequency of Experiencing Dryness Individual Item | 1 month Follow-up | Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here. |
| Subjective Overall Comfort Composite Score | Up to 1 month Follow-up | Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups. |
| Overall Comfort Individual Item | 1 month follow-up | Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here. |
| Comfort at the End of the Day Individual Item | 1 month Follow-up | Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision Individual Item | Up to 1 month Follow-up | Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here. |
| Overall Opinion Individual Item | Up to 1 month Follow-up | Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here. |
| Subjective Overall Quality of Vision Composite Score | Up to 1 month Follow-up | Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups. |
Countries
United States
Participant flow
Pre-assignment details
A total of 554 subjects were enrolled in this study. Of the enrolled subjects 6 subjects did not meet the eligibility criteria and 548 subjects were dispensed a study lens. Of the dispensed subjects 535 subjects completed the study and 13 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon C All subjects that wore the senofilcon C lens throughout the duration of the study. | 139 |
| Comfilcon A All subjects that wore the comfilcon A lens throughout the duration of the study. | 136 |
| Lotrafilcon B All subjects that wore the lotrafilcon B lens throughout the duration of the study. | 137 |
| Samfilcon A All subjects that wore the samfilcon A lens throughout the duration of the study. | 136 |
| Total | 548 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Did not wear lens at final visit | 0 | 1 | 0 | 0 |
| Overall Study | Dispensed incorrect study lens | 0 | 1 | 1 | 0 |
| Overall Study | Lens Discomfort | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Subject lost study lens | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Senofilcon C | Comfilcon A | Lotrafilcon B | Samfilcon A | Total |
|---|---|---|---|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 6.24 | 27.7 years STANDARD_DEVIATION 5.86 | 28.6 years STANDARD_DEVIATION 5.63 | 28.8 years STANDARD_DEVIATION 6.56 | 28.6 years STANDARD_DEVIATION 6.11 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 2 participants | 6 participants | 10 participants | 20 participants |
| Race/Ethnicity, Customized Black or African American | 13 participants | 10 participants | 9 participants | 12 participants | 44 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 1 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Other | 3 participants | 1 participants | 0 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized White | 119 participants | 122 participants | 122 participants | 113 participants | 476 participants |
| Region of Enrollment United States | 139 participants | 136 participants | 137 participants | 136 participants | 548 participants |
| Sex: Female, Male Female | 88 Participants | 98 Participants | 86 Participants | 92 Participants | 364 Participants |
| Sex: Female, Male Male | 51 Participants | 38 Participants | 51 Participants | 44 Participants | 184 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 139 | 0 / 136 | 0 / 137 | 0 / 136 |
| serious Total, serious adverse events | 0 / 139 | 0 / 136 | 0 / 137 | 1 / 136 |
Outcome results
Primary
Comfort at the End of the Day Individual Item
Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Time frame: 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Comfort at the End of the Day Individual Item | 3-Week Follow-up | 52.2 percentage of participants |
| Senofilcon C | Comfort at the End of the Day Individual Item | 1-Week Follow-up | 64.2 percentage of participants |
| Senofilcon C | Comfort at the End of the Day Individual Item | 4-Week Follow-up | 55.2 percentage of participants |
| Senofilcon C | Comfort at the End of the Day Individual Item | 2-Week Follow-up | 59.0 percentage of participants |
| Senofilcon C | Comfort at the End of the Day Individual Item | Baseline | 57.5 percentage of participants |
| Comfilcon A | Comfort at the End of the Day Individual Item | 2-Week Follow-up | 48.4 percentage of participants |
| Comfilcon A | Comfort at the End of the Day Individual Item | 3-Week Follow-up | 42.3 percentage of participants |
| Comfilcon A | Comfort at the End of the Day Individual Item | 4-Week Follow-up | 43.0 percentage of participants |
| Comfilcon A | Comfort at the End of the Day Individual Item | 1-Week Follow-up | 47.0 percentage of participants |
| Comfilcon A | Comfort at the End of the Day Individual Item | Baseline | 64.6 percentage of participants |
| Lotrafilcon B | Comfort at the End of the Day Individual Item | 2-Week Follow-up | 45.9 percentage of participants |
| Lotrafilcon B | Comfort at the End of the Day Individual Item | Baseline | 60.9 percentage of participants |
| Lotrafilcon B | Comfort at the End of the Day Individual Item | 1-Week Follow-up | 43.6 percentage of participants |
| Lotrafilcon B | Comfort at the End of the Day Individual Item | 3-Week Follow-up | 42.1 percentage of participants |
| Lotrafilcon B | Comfort at the End of the Day Individual Item | 4-Week Follow-up | 39.8 percentage of participants |
| Samfilcon A | Comfort at the End of the Day Individual Item | 3-Week Follow-up | 45.6 percentage of participants |
| Samfilcon A | Comfort at the End of the Day Individual Item | 1-Week Follow-up | 49.3 percentage of participants |
| Samfilcon A | Comfort at the End of the Day Individual Item | Baseline | 64.0 percentage of participants |
| Samfilcon A | Comfort at the End of the Day Individual Item | 2-Week Follow-up | 49.3 percentage of participants |
| Samfilcon A | Comfort at the End of the Day Individual Item | 4-Week Follow-up | 45.6 percentage of participants |
Primary
Comfort Each and Everyday Individual Item
Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Time frame: 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Comfort Each and Everyday Individual Item | Baseline | 73.2 percentage of participants |
| Senofilcon C | Comfort Each and Everyday Individual Item | 3-Week Follow-up | 70.9 percentage of participants |
| Senofilcon C | Comfort Each and Everyday Individual Item | 1-Week Follow-up | 79.1 percentage of participants |
| Senofilcon C | Comfort Each and Everyday Individual Item | 4-Week Follow-up | 68.7 percentage of participants |
| Senofilcon C | Comfort Each and Everyday Individual Item | 2-Week Follow-up | 70.9 percentage of participants |
| Comfilcon A | Comfort Each and Everyday Individual Item | 2-Week Follow-up | 58.5 percentage of participants |
| Comfilcon A | Comfort Each and Everyday Individual Item | 3-Week Follow-up | 54.6 percentage of participants |
| Comfilcon A | Comfort Each and Everyday Individual Item | Baseline | 76.1 percentage of participants |
| Comfilcon A | Comfort Each and Everyday Individual Item | 1-Week Follow-up | 59.2 percentage of participants |
| Comfilcon A | Comfort Each and Everyday Individual Item | 4-Week Follow-up | 54.6 percentage of participants |
| Lotrafilcon B | Comfort Each and Everyday Individual Item | 2-Week Follow-up | 52.6 percentage of participants |
| Lotrafilcon B | Comfort Each and Everyday Individual Item | Baseline | 78.3 percentage of participants |
| Lotrafilcon B | Comfort Each and Everyday Individual Item | 1-Week Follow-up | 54.2 percentage of participants |
| Lotrafilcon B | Comfort Each and Everyday Individual Item | 3-Week Follow-up | 48.2 percentage of participants |
| Lotrafilcon B | Comfort Each and Everyday Individual Item | 4-Week Follow-up | 48.9 percentage of participants |
| Samfilcon A | Comfort Each and Everyday Individual Item | 3-Week Follow-up | 53.0 percentage of participants |
| Samfilcon A | Comfort Each and Everyday Individual Item | 1-Week Follow-up | 56.6 percentage of participants |
| Samfilcon A | Comfort Each and Everyday Individual Item | Baseline | 76.5 percentage of participants |
| Samfilcon A | Comfort Each and Everyday Individual Item | 2-Week Follow-up | 53.0 percentage of participants |
| Samfilcon A | Comfort Each and Everyday Individual Item | 4-Week Follow-up | 52.2 percentage of participants |
Primary
Frequency of Experiencing Dryness Individual Item
Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Time frame: 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Frequency of Experiencing Dryness Individual Item | 3-Week Follow-up | 64.2 percentage of participants |
| Senofilcon C | Frequency of Experiencing Dryness Individual Item | 1-Week Follow-up | 67.9 percentage of participants |
| Senofilcon C | Frequency of Experiencing Dryness Individual Item | 4-Week Follow-up | 68.0 percentage of participants |
| Senofilcon C | Frequency of Experiencing Dryness Individual Item | 2-Week Follow-up | 67.2 percentage of participants |
| Senofilcon C | Frequency of Experiencing Dryness Individual Item | Baseline | 62.7 percentage of participants |
| Comfilcon A | Frequency of Experiencing Dryness Individual Item | 2-Week Follow-up | 50.1 percentage of participants |
| Comfilcon A | Frequency of Experiencing Dryness Individual Item | 3-Week Follow-up | 59.2 percentage of participants |
| Comfilcon A | Frequency of Experiencing Dryness Individual Item | 4-Week Follow-up | 55.4 percentage of participants |
| Comfilcon A | Frequency of Experiencing Dryness Individual Item | 1-Week Follow-up | 62.5 percentage of participants |
| Comfilcon A | Frequency of Experiencing Dryness Individual Item | Baseline | 67.7 percentage of participants |
| Lotrafilcon B | Frequency of Experiencing Dryness Individual Item | 2-Week Follow-up | 50.4 percentage of participants |
| Lotrafilcon B | Frequency of Experiencing Dryness Individual Item | Baseline | 71.4 percentage of participants |
| Lotrafilcon B | Frequency of Experiencing Dryness Individual Item | 1-Week Follow-up | 53.4 percentage of participants |
| Lotrafilcon B | Frequency of Experiencing Dryness Individual Item | 3-Week Follow-up | 51.2 percentage of participants |
| Lotrafilcon B | Frequency of Experiencing Dryness Individual Item | 4-Week Follow-up | 50.4 percentage of participants |
| Samfilcon A | Frequency of Experiencing Dryness Individual Item | 3-Week Follow-up | 56.6 percentage of participants |
| Samfilcon A | Frequency of Experiencing Dryness Individual Item | 1-Week Follow-up | 62.5 percentage of participants |
| Samfilcon A | Frequency of Experiencing Dryness Individual Item | Baseline | 67.6 percentage of participants |
| Samfilcon A | Frequency of Experiencing Dryness Individual Item | 2-Week Follow-up | 59.6 percentage of participants |
| Samfilcon A | Frequency of Experiencing Dryness Individual Item | 4-Week Follow-up | 55.9 percentage of participants |
Primary
Frequency of Lens Awareness Individual Item
Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Time frame: 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Frequency of Lens Awareness Individual Item | 3-Week Follow-up | 73.2 percentage of participants |
| Senofilcon C | Frequency of Lens Awareness Individual Item | 1-Week Follow-up | 75.4 percentage of participants |
| Senofilcon C | Frequency of Lens Awareness Individual Item | 4-Week Follow-up | 75.4 percentage of participants |
| Senofilcon C | Frequency of Lens Awareness Individual Item | 2-Week Follow-up | 78.3 percentage of participants |
| Senofilcon C | Frequency of Lens Awareness Individual Item | Baseline | 73.2 percentage of participants |
| Comfilcon A | Frequency of Lens Awareness Individual Item | 2-Week Follow-up | 63.9 percentage of participants |
| Comfilcon A | Frequency of Lens Awareness Individual Item | 3-Week Follow-up | 60.0 percentage of participants |
| Comfilcon A | Frequency of Lens Awareness Individual Item | 4-Week Follow-up | 60 percentage of participants |
| Comfilcon A | Frequency of Lens Awareness Individual Item | 1-Week Follow-up | 61.6 percentage of participants |
| Comfilcon A | Frequency of Lens Awareness Individual Item | Baseline | 74.5 percentage of participants |
| Lotrafilcon B | Frequency of Lens Awareness Individual Item | 2-Week Follow-up | 45.6 percentage of participants |
| Lotrafilcon B | Frequency of Lens Awareness Individual Item | Baseline | 77.4 percentage of participants |
| Lotrafilcon B | Frequency of Lens Awareness Individual Item | 1-Week Follow-up | 54.9 percentage of participants |
| Lotrafilcon B | Frequency of Lens Awareness Individual Item | 3-Week Follow-up | 54.2 percentage of participants |
| Lotrafilcon B | Frequency of Lens Awareness Individual Item | 4-Week Follow-up | 51.2 percentage of participants |
| Samfilcon A | Frequency of Lens Awareness Individual Item | 3-Week Follow-up | 59.6 percentage of participants |
| Samfilcon A | Frequency of Lens Awareness Individual Item | 1-Week Follow-up | 66.2 percentage of participants |
| Samfilcon A | Frequency of Lens Awareness Individual Item | Baseline | 75.8 percentage of participants |
| Samfilcon A | Frequency of Lens Awareness Individual Item | 2-Week Follow-up | 66.2 percentage of participants |
| Samfilcon A | Frequency of Lens Awareness Individual Item | 4-Week Follow-up | 63.2 percentage of participants |
Primary
Making Your Eyes Feel Moist Throughout the Day Individual Item
Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Time frame: Up to 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Making Your Eyes Feel Moist Throughout the Day Individual Item | 3-Week Follow-up | 61.2 percentage of participants |
| Senofilcon C | Making Your Eyes Feel Moist Throughout the Day Individual Item | 1-Week Follow-up | 58.6 percentage of participants |
| Senofilcon C | Making Your Eyes Feel Moist Throughout the Day Individual Item | 4-Week Follow-up | 64.9 percentage of participants |
| Senofilcon C | Making Your Eyes Feel Moist Throughout the Day Individual Item | 2-Week Follow-up | 58.2 percentage of participants |
| Senofilcon C | Making Your Eyes Feel Moist Throughout the Day Individual Item | Baseline | 68.6 percentage of participants |
| Comfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 2-Week Follow-up | 53.1 percentage of participants |
| Comfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 3-Week Follow-up | 48.5 percentage of participants |
| Comfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 4-Week Follow-up | 54.6 percentage of participants |
| Comfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 1-Week Follow-up | 52.3 percentage of participants |
| Comfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | Baseline | 52.3 percentage of participants |
| Lotrafilcon B | Making Your Eyes Feel Moist Throughout the Day Individual Item | 2-Week Follow-up | 49.7 percentage of participants |
| Lotrafilcon B | Making Your Eyes Feel Moist Throughout the Day Individual Item | Baseline | 43.7 percentage of participants |
| Lotrafilcon B | Making Your Eyes Feel Moist Throughout the Day Individual Item | 1-Week Follow-up | 43.7 percentage of participants |
| Lotrafilcon B | Making Your Eyes Feel Moist Throughout the Day Individual Item | 3-Week Follow-up | 45.9 percentage of participants |
| Lotrafilcon B | Making Your Eyes Feel Moist Throughout the Day Individual Item | 4-Week Follow-up | 43.6 percentage of participants |
| Samfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 3-Week Follow-up | 48.6 percentage of participants |
| Samfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 1-Week Follow-up | 55.2 percentage of participants |
| Samfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | Baseline | 55.2 percentage of participants |
| Samfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 2-Week Follow-up | 50.0 percentage of participants |
| Samfilcon A | Making Your Eyes Feel Moist Throughout the Day Individual Item | 4-Week Follow-up | 49.3 percentage of participants |
Primary
Overall Comfort Individual Item
Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Time frame: 1 month follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Overall Comfort Individual Item | 3-Week Follow-up | 69.4 percentage of participants |
| Senofilcon C | Overall Comfort Individual Item | 1-Week Follow-up | 79.1 percentage of participants |
| Senofilcon C | Overall Comfort Individual Item | 4-Week Follow-up | 68.7 percentage of participants |
| Senofilcon C | Overall Comfort Individual Item | 2-Week Follow-up | 70.9 percentage of participants |
| Senofilcon C | Overall Comfort Individual Item | Baseline | 78 percentage of participants |
| Comfilcon A | Overall Comfort Individual Item | 2-Week Follow-up | 54.7 percentage of participants |
| Comfilcon A | Overall Comfort Individual Item | 3-Week Follow-up | 50 percentage of participants |
| Comfilcon A | Overall Comfort Individual Item | 4-Week Follow-up | 54.6 percentage of participants |
| Comfilcon A | Overall Comfort Individual Item | 1-Week Follow-up | 50.7 percentage of participants |
| Comfilcon A | Overall Comfort Individual Item | Baseline | 82 percentage of participants |
| Lotrafilcon B | Overall Comfort Individual Item | 2-Week Follow-up | 48.2 percentage of participants |
| Lotrafilcon B | Overall Comfort Individual Item | Baseline | 80 percentage of participants |
| Lotrafilcon B | Overall Comfort Individual Item | 1-Week Follow-up | 51.9 percentage of participants |
| Lotrafilcon B | Overall Comfort Individual Item | 3-Week Follow-up | 45.2 percentage of participants |
| Lotrafilcon B | Overall Comfort Individual Item | 4-Week Follow-up | 46.2 percentage of participants |
| Samfilcon A | Overall Comfort Individual Item | 3-Week Follow-up | 53 percentage of participants |
| Samfilcon A | Overall Comfort Individual Item | 1-Week Follow-up | 56.6 percentage of participants |
| Samfilcon A | Overall Comfort Individual Item | Baseline | 77 percentage of participants |
| Samfilcon A | Overall Comfort Individual Item | 2-Week Follow-up | 54.5 percentage of participants |
| Samfilcon A | Overall Comfort Individual Item | 4-Week Follow-up | 50 percentage of participants |
Primary
Subjective Overall Comfort Composite Score
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.
Time frame: Up to 1 month Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon C | Subjective Overall Comfort Composite Score | Baseline | 65.17 average clue score | Standard Deviation 23.612 |
| Senofilcon C | Subjective Overall Comfort Composite Score | Post Fit | 66.65 average clue score | Standard Deviation 16.198 |
| Senofilcon C | Subjective Overall Comfort Composite Score | 1-Week Follow-up | 67.29 average clue score | Standard Deviation 22.863 |
| Senofilcon C | Subjective Overall Comfort Composite Score | 2-Week Follow-up | 64.18 average clue score | Standard Deviation 22.455 |
| Senofilcon C | Subjective Overall Comfort Composite Score | 3-Week Follow-up | 61.31 average clue score | Standard Deviation 23.85 |
| Senofilcon C | Subjective Overall Comfort Composite Score | 4-Week Follow-up | 60.74 average clue score | Standard Deviation 26.121 |
| Comfilcon A | Subjective Overall Comfort Composite Score | 4-Week Follow-up | 56.32 average clue score | Standard Deviation 27.549 |
| Comfilcon A | Subjective Overall Comfort Composite Score | 2-Week Follow-up | 55.56 average clue score | Standard Deviation 24.955 |
| Comfilcon A | Subjective Overall Comfort Composite Score | Baseline | 68.58 average clue score | Standard Deviation 21.993 |
| Comfilcon A | Subjective Overall Comfort Composite Score | 1-Week Follow-up | 55.78 average clue score | Standard Deviation 26.628 |
| Comfilcon A | Subjective Overall Comfort Composite Score | Post Fit | 62.11 average clue score | Standard Deviation 18.814 |
| Comfilcon A | Subjective Overall Comfort Composite Score | 3-Week Follow-up | 55.01 average clue score | Standard Deviation 27.069 |
| Lotrafilcon B | Subjective Overall Comfort Composite Score | Post Fit | 52.27 average clue score | Standard Deviation 22.762 |
| Lotrafilcon B | Subjective Overall Comfort Composite Score | 1-Week Follow-up | 54.40 average clue score | Standard Deviation 26.26 |
| Lotrafilcon B | Subjective Overall Comfort Composite Score | 2-Week Follow-up | 53.09 average clue score | Standard Deviation 26.908 |
| Lotrafilcon B | Subjective Overall Comfort Composite Score | 4-Week Follow-up | 51.15 average clue score | Standard Deviation 28.609 |
| Lotrafilcon B | Subjective Overall Comfort Composite Score | 3-Week Follow-up | 52.17 average clue score | Standard Deviation 26.585 |
| Lotrafilcon B | Subjective Overall Comfort Composite Score | Baseline | 66.45 average clue score | Standard Deviation 22.864 |
| Samfilcon A | Subjective Overall Comfort Composite Score | 3-Week Follow-up | 53.72 average clue score | Standard Deviation 26.794 |
| Samfilcon A | Subjective Overall Comfort Composite Score | 4-Week Follow-up | 52.61 average clue score | Standard Deviation 27.549 |
| Samfilcon A | Subjective Overall Comfort Composite Score | Post Fit | 64.40 average clue score | Standard Deviation 19.305 |
| Samfilcon A | Subjective Overall Comfort Composite Score | 2-Week Follow-up | 55.01 average clue score | Standard Deviation 24.817 |
| Samfilcon A | Subjective Overall Comfort Composite Score | Baseline | 65.46 average clue score | Standard Deviation 22.22 |
| Samfilcon A | Subjective Overall Comfort Composite Score | 1-Week Follow-up | 56.96 average clue score | Standard Deviation 25.508 |
Secondary
Overall Opinion Individual Item
Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Time frame: Up to 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Overall Opinion Individual Item | 3- Week Follow-up | 62.7 percentage of participants |
| Senofilcon C | Overall Opinion Individual Item | 1- Week Follow-up | 75.4 percentage of participants |
| Senofilcon C | Overall Opinion Individual Item | 4- Week Follow-up | 59.0 percentage of participants |
| Senofilcon C | Overall Opinion Individual Item | 2- Week Follow-up | 66.5 percentage of participants |
| Senofilcon C | Overall Opinion Individual Item | Post Fit | 85.8 percentage of participants |
| Comfilcon A | Overall Opinion Individual Item | 2- Week Follow-up | 47.7 percentage of participants |
| Comfilcon A | Overall Opinion Individual Item | 3- Week Follow-up | 43.9 percentage of participants |
| Comfilcon A | Overall Opinion Individual Item | 4- Week Follow-up | 43.9 percentage of participants |
| Comfilcon A | Overall Opinion Individual Item | 1- Week Follow-up | 49.3 percentage of participants |
| Comfilcon A | Overall Opinion Individual Item | Post Fit | 73.8 percentage of participants |
| Lotrafilcon B | Overall Opinion Individual Item | 2- Week Follow-up | 42.1 percentage of participants |
| Lotrafilcon B | Overall Opinion Individual Item | Post Fit | 60.9 percentage of participants |
| Lotrafilcon B | Overall Opinion Individual Item | 1- Week Follow-up | 42.1 percentage of participants |
| Lotrafilcon B | Overall Opinion Individual Item | 3- Week Follow-up | 42.9 percentage of participants |
| Lotrafilcon B | Overall Opinion Individual Item | 4- Week Follow-up | 38.3 percentage of participants |
| Samfilcon A | Overall Opinion Individual Item | 3- Week Follow-up | 39.7 percentage of participants |
| Samfilcon A | Overall Opinion Individual Item | 1- Week Follow-up | 54.5 percentage of participants |
| Samfilcon A | Overall Opinion Individual Item | Post Fit | 80.9 percentage of participants |
| Samfilcon A | Overall Opinion Individual Item | 2- Week Follow-up | 47.8 percentage of participants |
| Samfilcon A | Overall Opinion Individual Item | 4- Week Follow-up | 41.1 percentage of participants |
Secondary
Overall Quality of Vision Individual Item
Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Time frame: Up to 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon C | Overall Quality of Vision Individual Item | 3- Week Follow-up | 83.6 percentage of participants |
| Senofilcon C | Overall Quality of Vision Individual Item | 1- Week Follow-up | 89.5 percentage of participants |
| Senofilcon C | Overall Quality of Vision Individual Item | 4- Week Follow-up | 85.1 percentage of participants |
| Senofilcon C | Overall Quality of Vision Individual Item | 2- Week Follow-up | 82.8 percentage of participants |
| Senofilcon C | Overall Quality of Vision Individual Item | Baseline | 82.9 percentage of participants |
| Comfilcon A | Overall Quality of Vision Individual Item | 2- Week Follow-up | 77.7 percentage of participants |
| Comfilcon A | Overall Quality of Vision Individual Item | 3- Week Follow-up | 76.9 percentage of participants |
| Comfilcon A | Overall Quality of Vision Individual Item | 4- Week Follow-up | 76.2 percentage of participants |
| Comfilcon A | Overall Quality of Vision Individual Item | 1- Week Follow-up | 77.7 percentage of participants |
| Comfilcon A | Overall Quality of Vision Individual Item | Baseline | 86.9 percentage of participants |
| Lotrafilcon B | Overall Quality of Vision Individual Item | 2- Week Follow-up | 69.1 percentage of participants |
| Lotrafilcon B | Overall Quality of Vision Individual Item | Baseline | 91.0 percentage of participants |
| Lotrafilcon B | Overall Quality of Vision Individual Item | 1- Week Follow-up | 74.9 percentage of participants |
| Lotrafilcon B | Overall Quality of Vision Individual Item | 3- Week Follow-up | 69.9 percentage of participants |
| Lotrafilcon B | Overall Quality of Vision Individual Item | 4- Week Follow-up | 63.2 percentage of participants |
| Samfilcon A | Overall Quality of Vision Individual Item | 3- Week Follow-up | 66.9 percentage of participants |
| Samfilcon A | Overall Quality of Vision Individual Item | 1- Week Follow-up | 78.7 percentage of participants |
| Samfilcon A | Overall Quality of Vision Individual Item | Baseline | 84.5 percentage of participants |
| Samfilcon A | Overall Quality of Vision Individual Item | 2- Week Follow-up | 71.3 percentage of participants |
| Samfilcon A | Overall Quality of Vision Individual Item | 4- Week Follow-up | 61.0 percentage of participants |
Secondary
Subjective Overall Quality of Vision Composite Score
Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.
Time frame: Up to 1 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon C | Subjective Overall Quality of Vision Composite Score | Baseline | 63.79 units on a scale | Standard Deviation 20.515 |
| Senofilcon C | Subjective Overall Quality of Vision Composite Score | Post Fit | 69.45 units on a scale | Standard Deviation 14.896 |
| Senofilcon C | Subjective Overall Quality of Vision Composite Score | 1- Week Follow-up | 62.32 units on a scale | Standard Deviation 20.897 |
| Senofilcon C | Subjective Overall Quality of Vision Composite Score | 2- Week Follow-up | 64.77 units on a scale | Standard Deviation 20.222 |
| Senofilcon C | Subjective Overall Quality of Vision Composite Score | 3- Week Follow-up | 63.22 units on a scale | Standard Deviation 21.125 |
| Senofilcon C | Subjective Overall Quality of Vision Composite Score | 4- Week Follow-up | 63.30 units on a scale | Standard Deviation 22.852 |
| Comfilcon A | Subjective Overall Quality of Vision Composite Score | 4- Week Follow-up | 60.99 units on a scale | Standard Deviation 22.573 |
| Comfilcon A | Subjective Overall Quality of Vision Composite Score | 2- Week Follow-up | 61.66 units on a scale | Standard Deviation 20.504 |
| Comfilcon A | Subjective Overall Quality of Vision Composite Score | Baseline | 63.31 units on a scale | Standard Deviation 20.51 |
| Comfilcon A | Subjective Overall Quality of Vision Composite Score | 1- Week Follow-up | 63.55 units on a scale | Standard Deviation 20.586 |
| Comfilcon A | Subjective Overall Quality of Vision Composite Score | Post Fit | 68.96 units on a scale | Standard Deviation 16.272 |
| Comfilcon A | Subjective Overall Quality of Vision Composite Score | 3- Week Follow-up | 61.41 units on a scale | Standard Deviation 22.137 |
| Lotrafilcon B | Subjective Overall Quality of Vision Composite Score | Post Fit | 65.58 units on a scale | Standard Deviation 17.3 |
| Lotrafilcon B | Subjective Overall Quality of Vision Composite Score | 1- Week Follow-up | 59.36 units on a scale | Standard Deviation 22.076 |
| Lotrafilcon B | Subjective Overall Quality of Vision Composite Score | 2- Week Follow-up | 58.29 units on a scale | Standard Deviation 23.543 |
| Lotrafilcon B | Subjective Overall Quality of Vision Composite Score | 4- Week Follow-up | 56.63 units on a scale | Standard Deviation 24.879 |
| Lotrafilcon B | Subjective Overall Quality of Vision Composite Score | 3- Week Follow-up | 57.27 units on a scale | Standard Deviation 22.463 |
| Lotrafilcon B | Subjective Overall Quality of Vision Composite Score | Baseline | 64.12 units on a scale | Standard Deviation 19.822 |
| Samfilcon A | Subjective Overall Quality of Vision Composite Score | 3- Week Follow-up | 53.65 units on a scale | Standard Deviation 22.128 |
| Samfilcon A | Subjective Overall Quality of Vision Composite Score | 4- Week Follow-up | 53.57 units on a scale | Standard Deviation 23.1 |
| Samfilcon A | Subjective Overall Quality of Vision Composite Score | Post Fit | 67.07 units on a scale | Standard Deviation 16.741 |
| Samfilcon A | Subjective Overall Quality of Vision Composite Score | 2- Week Follow-up | 56.54 units on a scale | Standard Deviation 21.679 |
| Samfilcon A | Subjective Overall Quality of Vision Composite Score | Baseline | 62.34 units on a scale | Standard Deviation 19.383 |
| Samfilcon A | Subjective Overall Quality of Vision Composite Score | 1- Week Follow-up | 58.61 units on a scale | Standard Deviation 19.359 |