Visual Acuity
Conditions
Brief summary
This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.
Interventions
DEVICEACUVUE® DEFINE™ Vivid Style
TEST Lens
DEVICELACELLE™ Sparkling Brown
CONTROL Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 29 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 (ie, willing to wear only the study lenses and not use habitual lenses during the study). 3. Females between 18 and 29 (inclusive) years of age at the time of screening 4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -2.00 D to -7.00 D (inclusive) in each eye. 5. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye. 6. Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye. 7. 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. 8. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers. 9. The subject must be willing to be photographed and/or video-taped
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 |
|---|---|---|
| Visual Performance | Up to 2-Week Follow-up | Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain 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
China
Participant flow
Recruitment details
A total of 46 subjects were enrolled into this study. Of those enrolled 45 were dispensed at least 1 study lens. Of those dispensed, 41 subjects completed the study while 4 were discontinued.
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Protocol Violation | 1 | 0 |
| Period 1 | Unsatisfactory Lens Fitting Test Article | 3 | 0 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 23.6 years STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 45 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Region of Enrollment China | 45 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Visual Performance
Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain 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: Up to 2-Week Follow-up
Population: All subjects who had successfully completed all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Etafilcon A) | Visual Performance | High Luminnance Low Contrast | 0.40 logMAR Units | Standard Deviation 0.074 |
| Test (Etafilcon A) | Visual Performance | High Luminance High Contrast | -0.09 logMAR Units | Standard Deviation 0.053 |
| Test (Etafilcon A) | Visual Performance | Low Luminance High Contrast with Distance Goggles | -0.10 logMAR Units | Standard Deviation 0.055 |
| Control (Hefilcon A) | Visual Performance | High Luminnance Low Contrast | 0.38 logMAR Units | Standard Deviation 0.086 |
| Control (Hefilcon A) | Visual Performance | High Luminance High Contrast | -0.10 logMAR Units | Standard Deviation 0.059 |
| Control (Hefilcon A) | Visual Performance | Low Luminance High Contrast with Distance Goggles | -0.09 logMAR Units | Standard Deviation 0.055 |