Visual Acuity
Conditions
Brief summary
This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a total of 3 visits where all study endpoints will be measured in all subjects at baseline with habitual lenses and under the two testing treatments sequentially in separate visits based on the randomization scheme
Interventions
DEVICEsenofilcon A
Acuvue Oasys 1-Day
DEVICEControl
Trial Frame with best spherocylindrical refraction (SCR)
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 35 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. Between 18 and 35 (inclusive) years of age at the time of screening 4. The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month) 5. The subject must meet all of the following three criteria: 1. The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive) 2. The eyes' refractive cylinder must be less than or equal to -0.75 DC 3. Each eye must have best corrected visual acuity of 20/25 or better. 6. 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 or may impact the functioning of the tear film (e.g., Isotretinoin) 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. Any current use of ocular medication 6. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.) 7. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron scale 8. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear 9. Any known hypersensitivity or allergic reaction to contact lens care products. 10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment 11. Employee of clinical site (e.g., Investigator, Coordinator, Technician) 12. Current wearers of Acuvue Oasys 1-Day brand contact lenses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (logMAR) | 15 Minutes post Treatment Administration | Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under Contrast Sensitivity Function Curve | 15 minutes post treatment administration | Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) 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 patients 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. |
Countries
United States
Participant flow
Recruitment details
A total of 49 subjects were enrolled into this study. Of the enrolled subjects, 43 were dispensed at least one study article. Of the dispensed subjects all 43 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Total Dispensed All subjects dispensed at least one study treatment. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Total Dispensed |
|---|---|
| Age, Continuous | 26.8 Years STANDARD_DEVIATION 4.65 |
| Race/Ethnicity, Customized Asian | 8 Count of Participants |
| Race/Ethnicity, Customized Black or African American | 6 Count of Participants |
| Race/Ethnicity, Customized White | 29 Count of Participants |
| Region of Enrollment United States | 43 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Visual Acuity (logMAR)
Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.
Time frame: 15 Minutes post Treatment Administration
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Visual Acuity (logMAR) | High Luminance Low Contrast | 0.15 logMAR | Standard Deviation 0.108 |
| Test | Visual Acuity (logMAR) | Low Luminance high Contrast | 0.02 logMAR | Standard Deviation 0.097 |
| SCR (Subjective Spherorcylindrical Refraction) | Visual Acuity (logMAR) | High Luminance Low Contrast | 0.21 logMAR | Standard Deviation 0.13 |
| SCR (Subjective Spherorcylindrical Refraction) | Visual Acuity (logMAR) | Low Luminance high Contrast | 0.05 logMAR | Standard Deviation 0.102 |
Comparison: Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.97.5% CI: [-0.09, -0.02]Linear Mixed Model
97.5% CI: [-0.06, -0.01]Linear Mixed Model
Secondary
Area Under Contrast Sensitivity Function Curve
Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) 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 patients 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.
Time frame: 15 minutes post treatment administration
Population: All subjects who completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Area Under Contrast Sensitivity Function Curve | 1.39 log | Standard Deviation 0.135 |
| SCR (Subjective Spherorcylindrical Refraction) | Area Under Contrast Sensitivity Function Curve | 1.34 log | Standard Deviation 0.185 |
Comparison: Comparison between the Test and SCR treatments was carried out using least-square mean differencesp-value: 0.006695% CI: [0.01, 0.08]Linear Mixed Model