Visual Acuity
Conditions
Brief summary
This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.
Interventions
DEVICEsenofilcon A
TEST Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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. Between 18 and 39 (inclusive) years of age at the time of screening. 4. They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'. 5. Habitual spectacles must have resulted from an eye exam within the past six months. 6. The subject must have worn the updated spectacles for at least two weeks. 7. Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye. 8. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye. 9. The subject's refractive cylinder must be -1.00 D or less in each eye. 10. Have spherocylindrical best corrected distance Snellen 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 1. Currently pregnant or lactating. 2. Any active or ongoing 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 that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics). 4. Any current use of ocular medication. 5. Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist. 6. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 7. Employee or immediate family member of an employee of clinical site (e.g., 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. 9. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale. 10. Binocular vision abnormality or strabismus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable Lens Fitting | 4-Week Follow-up | Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling. |
Countries
United States
Participant flow
Recruitment details
A total of 129 subjects were enrolled in this study. Of those enrolled, 127 subjects were assigned and dispensed the Test lens while, 2 subjects failed to meet all eligibility criteria. Of those dispensed, 115 subjects completed the study while, 12 subjects were discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed the senofilcon A lens during any point in the study. | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failed Insertion & removal | 3 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Unsatisfactory Visual Response | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 25.3 Years STANDARD_DEVIATION 5.79 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Count of Participants |
| Race/Ethnicity, Customized Asian | 4 Count of Participants |
| Race/Ethnicity, Customized Black or African American | 16 Count of Participants |
| Race/Ethnicity, Customized Other | 5 Count of Participants |
| Race/Ethnicity, Customized White | 101 Count of Participants |
| Region of Enrollment United States | 127 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 127 |
| other Total, other adverse events | 0 / 127 |
| serious Total, serious adverse events | 0 / 127 |
Outcome results
Primary
Acceptable Lens Fitting
Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.
Time frame: 4-Week Follow-up
Population: All subjects who were administered a Test lens and completed through the 4-week evaluation in which the eye care practitioner completed the lens fitting assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A | Acceptable Lens Fitting | 0.974 Proportion of subjects |
Comparison: This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.95% CI: [0.925, 0.995]Binomial Exact Test