Visual Acuity
Conditions
Brief summary
This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy
Interventions
DEVICEsenofilcon A C3
TEST Lens
DEVICEsenofilcon A
CONTROL Lens
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: 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 silicone hydrogel soft contact lenses in both eyes in a daily reusable 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. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes. 7. The subject's refractive cylinder must be 1.00 D 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 lactating. 2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable. 4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 5. Be currently wearing lenses in a monovision, multifocal, toric, or extended wear modality. 6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment 7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 8. Have a history of binocular vision abnormality or strabismus. 9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 10. Have 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. 11\. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 13\. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Unacceptable Lens Fitting | Up to 2-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control. |
| Overall Quality of Vision Score | 2-Week Follow-up | Overall quality of vision score 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. The average CLUE vision score for each lens type was reported. |
| Distance Monocular logMAR Visual Acuity | 2-Week Follow-up | Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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. |
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | up to 2-week follow-up | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Scores | 2-Week Follow-up | Overall comfort scores were 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. The average CLUE comfort score for each lens type was reported. |
| Overall Handling Scores | 2-Week Follow-up | Overall handling scores were 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. The average CLUE handling score for each lens type was reported. |
| Situational Visual Performance - Indoors | 2-Week Follow-up | Indoor performance was assessed using the individual questionnaire item Clarity of Vision indoors in bright light with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies. |
| Situational Visual Performance - Digital Devices | 2-Week Follow-up | Situational visual performance related to digital device use was assessed using the individual preference item Overall preference while using computer screens & digital devices. The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies. |
Countries
United States
Participant flow
Recruitment details
A total of 296 subjects were enrolled in this study. Of those enrolled, 295 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 289 subjects completed the study while 6 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Control (Senofilcon A) Subjects that wore the Control (senofilcon A) lens during the study. | 150 |
| Test (Senofilcon A C3) Subjects that wore the Test lens during the study. | 145 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Study Procedure | 1 | 0 |
| Overall Study | Subject enrolled in error | 1 | 0 |
| Overall Study | Subject no longer meets eligibility criteria | 1 | 0 |
Baseline characteristics
| Characteristic | Control (Senofilcon A) | Total | Test (Senofilcon A C3) |
|---|---|---|---|
| Age, Continuous Age | 30.0 years STANDARD_DEVIATION 5.86 | 29.5 years STANDARD_DEVIATION 5.8 | 29.0 years STANDARD_DEVIATION 5.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 22 Participants | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 15 Participants | 8 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 131 Participants | 253 Participants | 122 Participants |
| Region of Enrollment United States | 150 Participants | 295 Participants | 145 Participants |
| Sex: Female, Male Gender Female | 102 Participants | 202 Participants | 100 Participants |
| Sex: Female, Male Gender Male | 48 Participants | 93 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 145 |
| other Total, other adverse events | 0 / 150 | 0 / 145 |
| serious Total, serious adverse events | 0 / 150 | 0 / 145 |
Outcome results
Primary
Distance Monocular logMAR Visual Acuity
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (Senofilcon A) | Distance Monocular logMAR Visual Acuity | -0.12 logMAR | Standard Deviation 0.093 |
| Test (Senofilcon A C3) | Distance Monocular logMAR Visual Acuity | -0.11 logMAR | Standard Deviation 0.08 |
Comparison: Based on the sample size calculation using a linear mixed model-based method with a 2-sided type I error of 0.05, there would be enough power (i.e., at least 80%) for testing non-inferiority of the Test relative to the Control with 16 subjects (8 for each lens group) competing the study assuming no difference between the Test and the Control.95% CI: [-0.02, 0.01]Linear Mixed Model
Primary
Overall Quality of Vision Score
Overall quality of vision score 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. The average CLUE vision score for each lens type was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (Senofilcon A) | Overall Quality of Vision Score | 67.0 Units on a scale | Standard Deviation 20.02 |
| Test (Senofilcon A C3) | Overall Quality of Vision Score | 70.4 Units on a scale | Standard Deviation 19.73 |
Comparison: Based on the sample size calculation using a two independent sample t test with a 2-sided type I error of 0.05, there would be enough power (i.e., 80%) for testing non-inferiority of the Test relative to the Control with 286 subjects (143 for each lens group) competing the study assuming the Test was 2 points higher than the Control.95% CI: [-0.6, 6.7]Linear Mixed Model
Primary
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported.
Time frame: up to 2-week follow-up
Population: All subjects were dispensed at least one study lens. Subjects were summarized by actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (Senofilcon A) | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 proportion of eyes |
| Test (Senofilcon A C3) | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 proportion of eyes |
Comparison: Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 240 subjects (120 for each lens group) competing the study assuming no difference between the Test and the Control.95% CI: [-0.004, 0.004]Bayesian hierarchical model
Primary
Proportion of Eyes With Unacceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control.
Time frame: Up to 2-Week Follow-up
Population: All subjects were dispensed at least one study lens. Subjects were summarized by actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (Senofilcon A) | Proportion of Eyes With Unacceptable Lens Fitting | 0 proportion of eyes |
| Test (Senofilcon A C3) | Proportion of Eyes With Unacceptable Lens Fitting | 0 proportion of eyes |
Comparison: Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 140 subjects (70 for each lens group) competing the study assuming no difference between the Test and the Control.95% CI: [-0.004, 0.004]Bayesian hierarchical model
Secondary
Overall Comfort Scores
Overall comfort scores were 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. The average CLUE comfort score for each lens type was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (Senofilcon A) | Overall Comfort Scores | 70.5 Units on a scale | Standard Deviation 22.83 |
| Test (Senofilcon A C3) | Overall Comfort Scores | 70.4 Units on a scale | Standard Deviation 22.66 |
Comparison: Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 73% for CLUE comfort using a two independent sample t test with a 2-sided type I error of 0.05.95% CI: [-4.8, 4.5]Linear Mixed Model
Secondary
Overall Handling Scores
Overall handling scores were 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. The average CLUE handling score for each lens type was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (Senofilcon A) | Overall Handling Scores | 69.2 Units on a scale | Standard Deviation 20.13 |
| Test (Senofilcon A C3) | Overall Handling Scores | 67.8 Units on a scale | Standard Deviation 20.44 |
Comparison: Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points lower than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 23% for CLUE handling using a two independent sample t test with a 2-sided type I error of 0.05.95% CI: [-6, 2.3]Linear Mixed Model
Secondary
Situational Visual Performance - Digital Devices
Situational visual performance related to digital device use was assessed using the individual preference item Overall preference while using computer screens & digital devices. The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies.
Time frame: 2-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (Senofilcon A) | Situational Visual Performance - Digital Devices | Slightly prefer my habitual lenses | 16 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Digital Devices | Slightly prefer the study lenses | 36 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Digital Devices | No Preference | 61 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Digital Devices | Strongly prefer the study lenses | 16 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Digital Devices | Strongly prefer my habitual lenses | 17 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Digital Devices | Strongly prefer the study lenses | 26 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Digital Devices | Strongly prefer my habitual lenses | 12 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Digital Devices | Slightly prefer my habitual lenses | 16 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Digital Devices | No Preference | 48 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Digital Devices | Slightly prefer the study lenses | 42 number of responses |
Comparison: Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of subjects preferring Study lens was 20% higher than preferring Habitual lens in the Test lens group, the estimated statistical power for testing superiority of the Test relative to the Habitual was 88% using a simulation approach with a 2-sided type I error of 0.05.95% CI: [1.4, 4.1]Linear Mixed Model
Secondary
Situational Visual Performance - Indoors
Indoor performance was assessed using the individual questionnaire item Clarity of Vision indoors in bright light with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (Senofilcon A) | Situational Visual Performance - Indoors | Excellent | 75 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Indoors | Good | 17 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Indoors | Fair | 1 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Indoors | Not Applicable | 0 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Indoors | Poor | 1 number of responses |
| Control (Senofilcon A) | Situational Visual Performance - Indoors | Very Good | 51 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Indoors | Poor | 0 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Indoors | Not Applicable | 0 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Indoors | Excellent | 85 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Indoors | Very Good | 48 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Indoors | Fair | 0 number of responses |
| Test (Senofilcon A C3) | Situational Visual Performance - Indoors | Good | 11 number of responses |
Comparison: Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of Excellent rating for the Test was 10% higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 93% using a Pearson chi-square test for two proportions with a 2-sided type I error of 0.05.95% CI: [0.83, 2.16]Linear Mixed Model