Visual Acuity
Conditions
Brief summary
This is a single visit, single site, 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.
Interventions
DEVICEJJVC Investigational Contact Lens
TEST
DEVICE1-DAY ACUVUE® DEFINE® Radiant Sweet™
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 -5.00 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 Binocular Visual Acuity (logMAR) | 20- Minutes Post-Lens Fitting | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles 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 value of 0.0 is equivalent to 20/20 Snellen vision. |
| Near BinocularVisual Acuity (logMAR) | 20- Minutes Post-Lens Fitting | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles 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 value of 0.0 is equivalent to 20/20 Snellen vision. |
| Quantitative Visual Acuity | 20- Minutes Post-Lens Fitting | Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision. |
| Area Under Contrast Sensitivity Function Curve | 20- Minutes Post-Lens Fitting | Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured. |
Countries
United States
Participant flow
Pre-assignment details
A total of 28 subjects were enrolled into this study. Of those enrolled 25 were dispensed study lenses and completed the study, while 3 subjects failed to meet all eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who were dispensed a study lens. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 26.1 years STANDARD_DEVIATION 4.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 15 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Area Under Contrast Sensitivity Function Curve
Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured.
Time frame: 20- Minutes Post-Lens Fitting
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Area Under Contrast Sensitivity Function Curve | Right Eye | 1.254 log contrast sensitivity*cpd | Standard Deviation 0.1746 |
| Test | Area Under Contrast Sensitivity Function Curve | Both Eyes | 1.524 log contrast sensitivity*cpd | Standard Deviation 0.1092 |
| Control | Area Under Contrast Sensitivity Function Curve | Right Eye | 1.273 log contrast sensitivity*cpd | Standard Deviation 0.1584 |
| Control | Area Under Contrast Sensitivity Function Curve | Both Eyes | 1.535 log contrast sensitivity*cpd | Standard Deviation 0.1022 |
Primary
Distance Binocular Visual Acuity (logMAR)
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles 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 value of 0.0 is equivalent to 20/20 Snellen vision.
Time frame: 20- Minutes Post-Lens Fitting
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 Binocular Visual Acuity (logMAR) | High Luminance High Contrast | -0.15 logMAR | Standard Deviation 0.074 |
| Test | Distance Binocular Visual Acuity (logMAR) | High Luminance Low Contrast | 0.00 logMAR | Standard Deviation 0.083 |
| Test | Distance Binocular Visual Acuity (logMAR) | Low Luminance High Contrast with goggles | 0.02 logMAR | Standard Deviation 0.094 |
| Control | Distance Binocular Visual Acuity (logMAR) | High Luminance High Contrast | -0.18 logMAR | Standard Deviation 0.069 |
| Control | Distance Binocular Visual Acuity (logMAR) | High Luminance Low Contrast | -0.04 logMAR | Standard Deviation 0.07 |
| Control | Distance Binocular Visual Acuity (logMAR) | Low Luminance High Contrast with goggles | 0.01 logMAR | Standard Deviation 0.065 |
Primary
Near BinocularVisual Acuity (logMAR)
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles 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 value of 0.0 is equivalent to 20/20 Snellen vision.
Time frame: 20- Minutes Post-Lens Fitting
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Near BinocularVisual Acuity (logMAR) | High Luminance Low Contrast | 0.04 logMAR | Standard Deviation 0.07 |
| Test | Near BinocularVisual Acuity (logMAR) | Low Luminance High Contrast with goggles | -0.02 logMAR | Standard Deviation 0.072 |
| Control | Near BinocularVisual Acuity (logMAR) | High Luminance Low Contrast | 0.02 logMAR | Standard Deviation 0.076 |
| Control | Near BinocularVisual Acuity (logMAR) | Low Luminance High Contrast with goggles | -0.04 logMAR | Standard Deviation 0.064 |
Primary
Quantitative Visual Acuity
Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision.
Time frame: 20- Minutes Post-Lens Fitting
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Quantitative Visual Acuity | Both Eyes | -0.010 logMAR | Standard Deviation 0.0578 |
| Test | Quantitative Visual Acuity | Right Eye | 0.061 logMAR | Standard Deviation 0.0889 |
| Control | Quantitative Visual Acuity | Right Eye | 0.051 logMAR | Standard Deviation 0.0749 |
| Control | Quantitative Visual Acuity | Both Eyes | -0.039 logMAR | Standard Deviation 0.0645 |