Visual Acuity
Conditions
Brief summary
This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.
Interventions
DEVICEsenofilcon A TEST Lens
JJVC Investigational Contact Lens
Acuvue Oasys
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 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must 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. Between 18 and 49 (inclusive) years of age at the time of informed consent. 4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision. 5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report. 6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week. 7. Subjects must own a wearable pair of distance spectacles. 8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye. 9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye. 10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 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. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis). 3. Subjects taking suspect oral medications for less than one year. 4. Any prescribed or over the counter (OTC) ocular medication. 5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution. 6. Toric, extended wear, monovision or multi-focal contact lens correction. 7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.). 8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment. 10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 11. Binocular vision abnormality or strabismus by self-report or prior medical history. 12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye. 13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study. 14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale. 15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision Satisfaction in Bright Lighting | 2-Week Follow-up Evaluation | Vision satisfaction in bright light was assessed using the individual item I was satisfied with the quality of my vision in bright lighting from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type. |
| Contact Lens Fitting Acceptance Rate | Up to 2-Week Follow-up | Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria: * limbal exposure at primary gaze or with extreme eye movement; * edge lift; * excessive movement in primary up gaze; * insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test. Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint. |
| Number of Grade 3 or Higher Slit Lamp Findings | Up to 2-Week Follow-up Evlauation | 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). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported. |
| Overall Comfort Score | 2-Week Follow-up Evlauation | Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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. |
| Distance Visual Acuity | 2-Week Follow-up Evlauation | Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination \> 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision Score | 2-Week Follow-up Evlauation | Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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. |
| Overall Handling Score | 2-Week Follow-up Evlauation | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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. |
Countries
United States
Participant flow
Recruitment details
A total of 253 subjects were enrolled into this study. Of those 2 subjects failed to meet all eligibility criteria and 251 subjects were dispensed a study lens. of the dispensed subjects 248 completed the study while 3 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects that wore the Test lens in both eyes during the entire duraiton of the study. | 125 |
| Control All subjects dispensed the Control lens in both eyes throughout the entire duration of the study. | 126 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Unsatisfactory Lens Fitting | 1 | 0 |
| Overall Study | Unsatisfactory Visual Response | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Total | Test |
|---|---|---|---|
| Age, Continuous | 31.7 Years STANDARD_DEVIATION 6.73 | 31.1 Years STANDARD_DEVIATION 6.67 | 30.5 Years STANDARD_DEVIATION 6.59 |
| Race/Ethnicity, Customized Asian | 11 Participants | 21 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 109 Participants | 224 Participants | 115 Participants |
| Region of Enrollment United States | 126 Participants | 251 Participants | 125 Participants |
| Sex: Female, Male Female | 84 Participants | 169 Participants | 85 Participants |
| Sex: Female, Male Male | 42 Participants | 82 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 126 |
| other Total, other adverse events | 0 / 125 | 0 / 126 |
| serious Total, serious adverse events | 0 / 125 | 0 / 126 |
Outcome results
Primary
Contact Lens Fitting Acceptance Rate
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria: * limbal exposure at primary gaze or with extreme eye movement; * edge lift; * excessive movement in primary up gaze; * insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test. Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.
Time frame: Up to 2-Week Follow-up
Population: All subjects that were dispsensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Contact Lens Fitting Acceptance Rate | 99.2 Percentage of eyes |
| Control | Contact Lens Fitting Acceptance Rate | 100 Percentage of eyes |
Comparison: It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.95% CI: [98.5, 100]Bayesian Beta-Binomial Model
Primary
Distance Visual Acuity
Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination \> 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.
Time frame: 2-Week Follow-up Evlauation
Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Distance Visual Acuity | -0.131 logMAR | Standard Deviation 0.0913 |
| Control | Distance Visual Acuity | -0.107 logMAR | Standard Deviation 0.0861 |
Comparison: It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.95% CI: [-0.04, -0.01]Bayesian Normal Random effects model
Primary
Number of 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). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.
Time frame: Up to 2-Week Follow-up Evlauation
Population: All subjects that were dispensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Number of Grade 3 or Higher Slit Lamp Findings | 0 Number of eyes |
| Control | Number of Grade 3 or Higher Slit Lamp Findings | 0 Number of eyes |
Comparison: It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.95% CI: [-0.007, 0.008]Bayesian beta-binomial model
Primary
Overall Comfort Score
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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.
Time frame: 2-Week Follow-up Evlauation
Population: All subjects that completed the study without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Comfort Score | 64.7 Units on a Scale | Standard Deviation 21.33 |
| Control | Overall Comfort Score | 62.6 Units on a Scale | Standard Deviation 23.38 |
Comparison: It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).95% CI: [-2, 8.5]Bayesian normal random-effects
Primary
Vision Satisfaction in Bright Lighting
Vision satisfaction in bright light was assessed using the individual item I was satisfied with the quality of my vision in bright lighting from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type.
Time frame: 2-Week Follow-up Evaluation
Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Vision Satisfaction in Bright Lighting | Strongly Agree | 30.3 Percentage of subjects |
| Test | Vision Satisfaction in Bright Lighting | Agree | 59.0 Percentage of subjects |
| Test | Vision Satisfaction in Bright Lighting | Neither Agree nor Disagree | 6.6 Percentage of subjects |
| Test | Vision Satisfaction in Bright Lighting | Disagree | 4.1 Percentage of subjects |
| Test | Vision Satisfaction in Bright Lighting | Strongly Disagree | 0 Percentage of subjects |
| Control | Vision Satisfaction in Bright Lighting | Strongly Disagree | 0.8 Percentage of subjects |
| Control | Vision Satisfaction in Bright Lighting | Strongly Agree | 19.4 Percentage of subjects |
| Control | Vision Satisfaction in Bright Lighting | Disagree | 8.1 Percentage of subjects |
| Control | Vision Satisfaction in Bright Lighting | Agree | 58.1 Percentage of subjects |
| Control | Vision Satisfaction in Bright Lighting | Neither Agree nor Disagree | 12.9 Percentage of subjects |
Comparison: It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).95% CI: [0.02, 0.15]Bayesian random -effects model
Secondary
Overall Handling Score
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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.
Time frame: 2-Week Follow-up Evlauation
Population: All subjects that completed the study without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Handling Score | 70.9 Units on a Scale | Standard Deviation 17.24 |
| Control | Overall Handling Score | 68.7 Units on a Scale | Standard Deviation 18.55 |
Comparison: Sample Size was based on primary endpoints only.95% CI: [-1.3, 6.3]Bayesian normal random-effects
Secondary
Overall Quality of Vision Score
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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.
Time frame: 2-Week Follow-up Evlauation
Population: All subjects that completed the study without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Quality of Vision Score | 66.4 Units on a Scale | Standard Deviation 19.19 |
| Control | Overall Quality of Vision Score | 60.9 Units on a Scale | Standard Deviation 22.33 |
Comparison: Sample Size was based on primary endpoints only.95% CI: [3.48, 12.54]Bayesian normal random-effects