Visual Acuity
Conditions
Brief summary
This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
Interventions
DEVICETest 8.5BC
senofilcon A contact lenses with 8.5 base curve
DEVICETest 9.0BC
senofilcon A contact lenses with 9.0 base curve
DEVICEControl 8.5BC
narafilcon A contact lenses with 8.5 base curve
DEVICEControl 9.0BC
narafilcon A contact lenses with 9.0 base curve
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the investigator and the subjects are masked to the identity of the study lenses. Lenses were over-labelled and coded to mask the lens foil. Over-labelling was carried out by the study sponsor following specific SOPs (see ICH GCP guidelines Section 5.13).
Intervention model description
Contra-lateral Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 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 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 aged 18-55 years. 4. The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -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 6/9 (20/30) or better for each eye. 7. The subject is a current 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). 8. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating 2. Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. 3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. 4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. 5. Extended wear contact lens correction. 6. Any current use of ocular medication. 7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.) 8. Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear. 9. Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear. 10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment. 11. 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 |
|---|---|---|
| Overall Fit Acceptance | 30-45 minutes after lens settling | Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported. |
| Lens Power Requirement | 30-45 minutes after lens settling | The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Vision Quality | 30-45 minutes after lens settling | Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported. |
| Subjective Comfort at Lens Insertion | Immediately upon lens insertion | Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. |
| Monocular High Contrast Visual Acuity (VA) | 30-45 minutes after lens settling | Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type. |
| Subjective Handling | Immediately upon lens insertion | Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported. |
| Subjective Comfort After Lens Settling | 30-45 minutes after lens settling | Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 51 subjects were enrolled in the study from two sites. Of those enrolled, 50 subjects were randomized and 50 subjects were dispensed a study lens. All 50 subjects completed the study, while no one discontinued from the study.
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 30.3 years STANDARD_DEVIATION 13.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United Kingdom | 50 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Lens Power Requirement
The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).
Time frame: 30-45 minutes after lens settling
Population: All subjects who had successfully completed all required assessments without a major protocol deviation.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test 8.5BC | Lens Power Requirement | -2.00 t -1.50 | 9 Eyes |
| Test 8.5BC | Lens Power Requirement | <= -3.75 | 10 Eyes |
| Test 8.5BC | Lens Power Requirement | -1.25 to -0.75 | 2 Eyes |
| Test 8.5BC | Lens Power Requirement | >= -0.50 | 3 Eyes |
| Test 8.5BC | Lens Power Requirement | -3.50 to -3.00 | 7 Eyes |
| Test 8.5BC | Lens Power Requirement | -2.75 to -2.25 | 17 Eyes |
| Test 9.0BC | Lens Power Requirement | -2.75 to -2.25 | 15 Eyes |
| Test 9.0BC | Lens Power Requirement | -2.00 t -1.50 | 10 Eyes |
| Test 9.0BC | Lens Power Requirement | -1.25 to -0.75 | 2 Eyes |
| Test 9.0BC | Lens Power Requirement | -3.50 to -3.00 | 9 Eyes |
| Test 9.0BC | Lens Power Requirement | <= -3.75 | 9 Eyes |
| Test 9.0BC | Lens Power Requirement | >= -0.50 | 3 Eyes |
| Control 8.5BC | Lens Power Requirement | -3.50 to -3.00 | 7 Eyes |
| Control 8.5BC | Lens Power Requirement | <= -3.75 | 10 Eyes |
| Control 8.5BC | Lens Power Requirement | -2.75 to -2.25 | 16 Eyes |
| Control 8.5BC | Lens Power Requirement | -2.00 t -1.50 | 10 Eyes |
| Control 8.5BC | Lens Power Requirement | -1.25 to -0.75 | 3 Eyes |
| Control 8.5BC | Lens Power Requirement | >= -0.50 | 2 Eyes |
| Control 9.0BC | Lens Power Requirement | >= -0.50 | 3 Eyes |
| Control 9.0BC | Lens Power Requirement | -1.25 to -0.75 | 2 Eyes |
| Control 9.0BC | Lens Power Requirement | <= -3.75 | 8 Eyes |
| Control 9.0BC | Lens Power Requirement | -3.50 to -3.00 | 10 Eyes |
| Control 9.0BC | Lens Power Requirement | -2.00 t -1.50 | 10 Eyes |
| Control 9.0BC | Lens Power Requirement | -2.75 to -2.25 | 15 Eyes |
97.5% CI: [81.1, 98.1]Wilson Method
97.5% CI: [68.3, 92.1]Wilson Method
97.5% CI: [90.5, 100]Wilson Method
97.5% CI: [90.5, 100]Wilson Method
Primary
Overall Fit Acceptance
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
Time frame: 30-45 minutes after lens settling
Population: All subjects who had successfully completed all required assessments visits without any a major protocol deviations.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test 8.5BC | Overall Fit Acceptance | 0 | 0 Eyes |
| Test 8.5BC | Overall Fit Acceptance | 1 | 0 Eyes |
| Test 8.5BC | Overall Fit Acceptance | 2 | 1 Eyes |
| Test 8.5BC | Overall Fit Acceptance | 3 | 5 Eyes |
| Test 8.5BC | Overall Fit Acceptance | 4 | 17 Eyes |
| Test 8.5BC | Overall Fit Acceptance | 5 | 25 Eyes |
| Test 9.0BC | Overall Fit Acceptance | 5 | 14 Eyes |
| Test 9.0BC | Overall Fit Acceptance | 3 | 8 Eyes |
| Test 9.0BC | Overall Fit Acceptance | 0 | 0 Eyes |
| Test 9.0BC | Overall Fit Acceptance | 2 | 2 Eyes |
| Test 9.0BC | Overall Fit Acceptance | 1 | 0 Eyes |
| Test 9.0BC | Overall Fit Acceptance | 4 | 24 Eyes |
| Control 8.5BC | Overall Fit Acceptance | 1 | 0 Eyes |
| Control 8.5BC | Overall Fit Acceptance | 2 | 1 Eyes |
| Control 8.5BC | Overall Fit Acceptance | 3 | 5 Eyes |
| Control 8.5BC | Overall Fit Acceptance | 5 | 23 Eyes |
| Control 8.5BC | Overall Fit Acceptance | 4 | 19 Eyes |
| Control 8.5BC | Overall Fit Acceptance | 0 | 0 Eyes |
| Control 9.0BC | Overall Fit Acceptance | 4 | 17 Eyes |
| Control 9.0BC | Overall Fit Acceptance | 5 | 19 Eyes |
| Control 9.0BC | Overall Fit Acceptance | 1 | 0 Eyes |
| Control 9.0BC | Overall Fit Acceptance | 3 | 7 Eyes |
| Control 9.0BC | Overall Fit Acceptance | 0 | 0 Eyes |
| Control 9.0BC | Overall Fit Acceptance | 2 | 5 Eyes |
95% CI: [0.46, 3.06]Generalized linear mixed model
95% CI: [0.34, 2.52]Generalized linear mixed model
Secondary
Monocular High Contrast Visual Acuity (VA)
Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.
Time frame: 30-45 minutes after lens settling
Population: All subjects who had successfully completed all required assessments without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 8.5BC | Monocular High Contrast Visual Acuity (VA) | -0.02 logMAR | Standard Deviation 0.068 |
| Test 9.0BC | Monocular High Contrast Visual Acuity (VA) | -0.02 logMAR | Standard Deviation 0.083 |
| Control 8.5BC | Monocular High Contrast Visual Acuity (VA) | -0.02 logMAR | Standard Deviation 0.064 |
| Control 9.0BC | Monocular High Contrast Visual Acuity (VA) | -0.02 logMAR | Standard Deviation 0.061 |
95% CI: [-0.009, 0.012]Linear mixed model
95% CI: [-0.012, 0.009]Linear mixed model
Secondary
Subjective Comfort After Lens Settling
Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Time frame: 30-45 minutes after lens settling
Population: All subjects who had successfully completed all required assessments without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 8.5BC | Subjective Comfort After Lens Settling | 9.50 Graded scale 0-10 | Standard Deviation 0.715 |
| Test 9.0BC | Subjective Comfort After Lens Settling | 9.27 Graded scale 0-10 | Standard Deviation 1.005 |
| Control 8.5BC | Subjective Comfort After Lens Settling | 9.56 Graded scale 0-10 | Standard Deviation 0.769 |
| Control 9.0BC | Subjective Comfort After Lens Settling | 9.13 Graded scale 0-10 | Standard Deviation 1.214 |
95% CI: [-0.4, 0.3]Linear mixed model
95% CI: [-0.2, 0.5]Linear mixed model
Secondary
Subjective Comfort at Lens Insertion
Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Time frame: Immediately upon lens insertion
Population: All subjects who had successfully completed all required assessments without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 8.5BC | Subjective Comfort at Lens Insertion | 9.15 Graded Scale 0-10 | Standard Deviation 1.353 |
| Test 9.0BC | Subjective Comfort at Lens Insertion | 9.04 Graded Scale 0-10 | Standard Deviation 1.22 |
| Control 8.5BC | Subjective Comfort at Lens Insertion | 8.92 Graded Scale 0-10 | Standard Deviation 1.302 |
| Control 9.0BC | Subjective Comfort at Lens Insertion | 9.02 Graded Scale 0-10 | Standard Deviation 1.176 |
95% CI: [-0.3, 0.7]Linear mixed model
95% CI: [-0.5, 0.5]Linear mixed model
Secondary
Subjective Handling
Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.
Time frame: Immediately upon lens insertion
Population: All subjects who had successfully completed all required assessments without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 8.5BC | Subjective Handling | 9.17 Graded scale 0-10 | Standard Deviation 1.243 |
| Test 9.0BC | Subjective Handling | 9.10 Graded scale 0-10 | Standard Deviation 1.242 |
| Control 8.5BC | Subjective Handling | 9.13 Graded scale 0-10 | Standard Deviation 1.248 |
| Control 9.0BC | Subjective Handling | 9.25 Graded scale 0-10 | Standard Deviation 1.139 |
95% CI: [-0.5, 0.5]Linear mixed model
95% CI: [-0.6, 0.4]Linear mixed model
Secondary
Subjective Vision Quality
Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.
Time frame: 30-45 minutes after lens settling
Population: All subjects who had successfully completed all required assessments without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 8.5BC | Subjective Vision Quality | 9.33 Graded scale 0-10 | Standard Deviation 0.753 |
| Test 9.0BC | Subjective Vision Quality | 9.25 Graded scale 0-10 | Standard Deviation 0.911 |
| Control 8.5BC | Subjective Vision Quality | 9.19 Graded scale 0-10 | Standard Deviation 1.104 |
| Control 9.0BC | Subjective Vision Quality | 9.19 Graded scale 0-10 | Standard Deviation 1.065 |
95% CI: [-0.1, 0.4]Linear mixed model
95% CI: [-0.2, 0.3]Linear mixed model