Visual Acuity
Conditions
Brief summary
This is a single visit, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods in a random order with a 5-minute washout period in between study lenses.
Interventions
DEVICEetafilcon A with cosmetic pattern
TEST
DEVICE1-Day Acuvue DEFINE Vivid Style
CONTROL
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 39 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. Subjects between 18 and 39 (inclusive) years of age at the time of screening 4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report. 5. The subject must be willing to be photographed and/or video-taped. 6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye 7. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye. 8. Have spherical 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. Currently pregnant or lactating 2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion). 3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion) 4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.) 5. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment 6. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician). 7. 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 (at the investigators discretion). 8. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Monocular Visual Acuity (logMAR) | 5 min post lens insertion | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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. |
Countries
United States
Participant flow
Recruitment details
A total of 35 subjects were enrolled in this study. Of those enrolled, all 35 subjects were dispensed both study lenses and completed the study.
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 5.36 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 32 participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Distance Monocular Visual Acuity (logMAR)
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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: 5 min post lens insertion
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Distance Monocular Visual Acuity (logMAR) | High Luminance Low Contrast | -0.016 logMAR | Standard Deviation 0.1083 |
| Test | Distance Monocular Visual Acuity (logMAR) | High Luminance High Contrast | -0.171 logMAR | Standard Deviation 0.0857 |
| Test | Distance Monocular Visual Acuity (logMAR) | Low Luminance High Contrast | 0.016 logMAR | Standard Deviation 0.1008 |
| Control | Distance Monocular Visual Acuity (logMAR) | High Luminance Low Contrast | -0.001 logMAR | Standard Deviation 0.1046 |
| Control | Distance Monocular Visual Acuity (logMAR) | High Luminance High Contrast | -0.151 logMAR | Standard Deviation 0.0852 |
| Control | Distance Monocular Visual Acuity (logMAR) | Low Luminance High Contrast | 0.007 logMAR | Standard Deviation 0.0814 |
Comparison: High Luminance Low Contrast95% CI: [-0.039, 0.006]Mixed Models Analysis
Comparison: Low Luminance High Contrast95% CI: [-0.014, 0.031]Mixed Models Analysis