Visual Acuity
Conditions
Brief summary
This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. The subject will wear either the Test or Control lens twice and the other study lens once.
Interventions
DEVICECONTROL Lens
Acuvue OASYS
DEVICETEST Lens
senofilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read and sign the Informed Consent form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them. 4. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D. 5. The subject's refractive cylinder must be ≤ 1.00 D in each eye. 6. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. 7. Subjects must own a wearable pair of spectacles. 8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis. 9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week. 10. 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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. 5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.). 6. 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. 7. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution. 8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. 9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 10. Toric, extended wear, monovision or multi-focal contact lens correction. 11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment. 13. History of binocular vision abnormality or strabismus. 14. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of 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 and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported. |
| Vision Satisfaction in Bright Lighting | 2-Week Follow-up | 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. |
| Distance Monocular LogMAR Visual Acuity | 2-Week Follow-up | Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination \> 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination \<2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported. |
| Contact Lens Fitting Acceptance Rate | Up to 2-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens. |
| Overall Comfort Score | 2-Week Follow-up | Overall comfort 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Handling Scores | 2-Week Follow-up | Overall handling 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. |
| Overall Quality of Vision Indoors | 2-Week Follow-up | Overall Quality of Vision Indoors was assessed using the individual item Overall Quality of Vision Indoors from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type. |
| Overall Quality of Vision Score | 2-Week Follow-up | 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 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. |
Countries
United States
Participant flow
Recruitment details
A total of 126 subjects were enrolled into this study. Of those enrolled, 120 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 110 completed the study, while 10 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed at least one study lens regardless of randomization. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 1 |
| Period 1 | Lost to Follow-up | 0 | 1 |
| Period 1 | No longer meet eligibility criteria | 1 | 0 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
| Period 2 | Adverse Event | 2 | 1 |
| Period 2 | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 33.3 Years STANDARD_DEVIATION 8.02 |
| Race/Ethnicity, Customized Asian | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized White | 102 Participants |
| Region of Enrollment United States | 120 Participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 120 |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
Outcome results
Primary
Contact Lens Fitting Acceptance Rate
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Contact Lens Fitting Acceptance Rate | 100 percentage of eyes |
| Control | Contact Lens Fitting Acceptance Rate | 100 percentage of eyes |
Comparison: It was calculated that 65 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: [99, 100]Bayesian beta- binomial model
Primary
Distance Monocular LogMAR Visual Acuity
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination \> 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination \<2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.
Time frame: 2-Week Follow-up
Population: subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Distance Monocular LogMAR Visual Acuity | High Illumination low contrast | 0.10 logMAR | Standard Deviation 0.086 |
| Test | Distance Monocular LogMAR Visual Acuity | Low illumination high contrast | 0.06 logMAR | Standard Deviation 0.082 |
| Control | Distance Monocular LogMAR Visual Acuity | High Illumination low contrast | 0.14 logMAR | Standard Deviation 0.089 |
| Control | Distance Monocular LogMAR Visual Acuity | Low illumination high contrast | 0.08 logMAR | Standard Deviation 0.085 |
Comparison: It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the low luminance high contrast lighting condition.95% CI: [-0.037, -0.008]Bayesian multivariate normal model
Comparison: It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the high illumination low contrast lighting condition.95% CI: [-0.049, -0.02]Bayesian multivariate normal 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.
Time frame: Up to 2-Week Follow-up
Population: All subjects dispensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Number of Grade 3 or Higher Slit Lamp Findings | 0.005 proportion of eyes |
| Control | Number of Grade 3 or Higher Slit Lamp Findings | 0.000 proportion of eyes |
Comparison: It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences 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.95% CI: [-0.004, 0.008]Bayesian beta-binomial hierarchical
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 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.
Time frame: 2-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Comfort Score | 59.30 Units on a Scale | Standard Deviation 23.779 |
| Control | Overall Comfort Score | 58.54 Units on a Scale | Standard Deviation 22.303 |
Comparison: It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).95% CI: [-1.9, 5.8]Bayesian multivariate normal random-effe
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
Population: subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Vision Satisfaction in Bright Lighting | Agree | 0.622 Proportion of participants |
| Test | Vision Satisfaction in Bright Lighting | Disagree | 0.061 Proportion of participants |
| Test | Vision Satisfaction in Bright Lighting | Neither Agree Nor Agree | 0.098 Proportion of participants |
| Test | Vision Satisfaction in Bright Lighting | Strongly Disagree | 0.00 Proportion of participants |
| Test | Vision Satisfaction in Bright Lighting | Strongly Agree | 0.22 Proportion of participants |
| Control | Vision Satisfaction in Bright Lighting | Strongly Disagree | 0.031 Proportion of participants |
| Control | Vision Satisfaction in Bright Lighting | Strongly Agree | 0.11 Proportion of participants |
| Control | Vision Satisfaction in Bright Lighting | Agree | 0.583 Proportion of participants |
| Control | Vision Satisfaction in Bright Lighting | Neither Agree Nor Agree | 0.141 Proportion of participants |
| Control | Vision Satisfaction in Bright Lighting | Disagree | 0.135 Proportion of participants |
95% CI: [2.27, 6.62]Bayesian multinomial random-effects mode
Secondary
Overall Handling Scores
Overall handling 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.
Time frame: 2-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Handling Scores | 66.24 Units on a Scale | Standard Deviation 19.185 |
| Control | Overall Handling Scores | 64.66 Units on a Scale | Standard Deviation 20.46 |
Comparison: Sample size was based on primary endpoints only.95% CI: [-0.6, 5.5]Bayesian multivariate normal model
Secondary
Overall Quality of Vision Indoors
Overall Quality of Vision Indoors was assessed using the individual item Overall Quality of Vision Indoors from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type.
Time frame: 2-Week Follow-up
Population: subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Quality of Vision Indoors | Very Good | 0.396 Proportion of participants |
| Test | Overall Quality of Vision Indoors | Excellent | 0.433 Proportion of participants |
| Test | Overall Quality of Vision Indoors | Poor | 0 Proportion of participants |
| Test | Overall Quality of Vision Indoors | Good | 0.128 Proportion of participants |
| Test | Overall Quality of Vision Indoors | Not Applicable | 0 Proportion of participants |
| Test | Overall Quality of Vision Indoors | Fair | 0.043 Proportion of participants |
| Control | Overall Quality of Vision Indoors | Not Applicable | 0 Proportion of participants |
| Control | Overall Quality of Vision Indoors | Excellent | 0.374 Proportion of participants |
| Control | Overall Quality of Vision Indoors | Very Good | 0.393 Proportion of participants |
| Control | Overall Quality of Vision Indoors | Good | 0.184 Proportion of participants |
| Control | Overall Quality of Vision Indoors | Fair | 0.049 Proportion of participants |
| Control | Overall Quality of Vision Indoors | Poor | 0 Proportion of participants |
95% CI: [1, 2.82]Bayesian multinomial 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 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.
Time frame: 2-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Quality of Vision Score | 62.25 Units on a Scale | Standard Deviation 18.46 |
| Control | Overall Quality of Vision Score | 58.47 Units on a Scale | Standard Deviation 18.707 |
Comparison: Sample size was based on primary endpoints only.95% CI: [3.1, 8.1]Bayesian multivariate normal model