Visual Acuity
Conditions
Brief summary
This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.
Interventions
DEVICEetafilcon A investigational cosmetic lens 1
TEST
DEVICEetafilcon A investigational cosmetic lens 2
CONTROL
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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. Females between 18 and 29 (inclusive) years of age at the time of screening 3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods) 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. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report. 6. The subject must be willing to be photographed and/or video-taped 7. 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 8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye 9. Have spherical best corrected visual acuity of 20/25 or better in each eye.
Exclusion criteria
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. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion). 6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment 7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician) 8. 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) 9. 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 |
|---|---|---|
| Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR | 5- 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 lighting condition 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. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported. |
Countries
Hong Kong, United States
Participant flow
Recruitment details
A total of 58 subjects were enrolled into this study. Of those enrolled, 56 were dispensed at least 1 study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 55 subjects completed the study while 1 subject was discontinued.
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Unsatisfactory Lens Fitting due to Test Article | 0 | 1 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 23.1 years STANDARD_DEVIATION 2.42 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian | 41 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 9 participants |
| Region of Enrollment China | 39 participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 56 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 / 55 | 0 / 56 |
| other Total, other adverse events | 0 / 55 | 0 / 56 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 |
Outcome results
Primary
Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
Time frame: 5- Minutes Post-Lens Fitting
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test (Etafilcon A With Cosmetic Pattern) | Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR | 0.9998 proportion of eyes |
| Control (Etafilcon A With Cosmetic Pattern) | Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR | 0.9998 proportion of eyes |
95% CI: [0.999, 1]Bayesian Binary model