Visual Acuity
Conditions
Brief summary
This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.
Interventions
DEVICEAcuvue® Oasys MAX 1-Day
TEST Lens
DEVICEDailies Total 1
CONTROL Lens
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 40 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 40 (inclusive) years of age at the time of screening. 4. They agree not to participate in other clinical research while enrolled on this study. 5. They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks. 6. They own a wearable pair of spectacles if needed for distance vision correction (by self-report). 7. They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye. 8. They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction). 9. They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
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 or may pose a risk to study personnel. 3. They have an ocular disorder which would normally contraindicate contact lens wear. 4. They have had cataract surgery. 5. They have had corneal refractive surgery. 6. They are using any topical medications such as eye drops or ointments. 7. Any known hypersensitivity or allergic reaction to sodium fluorescein. 8. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications. 9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment. 10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 11. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 12. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 13. They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Acceptable Lens Fitting | Up to 2-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 16 subjects were enrolled in this study. Of those enrolled, 14 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. All dispensed subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects dispensed a study lens. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 31.1 Years STANDARD_DEVIATION 6.73 |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Region of Enrollment United Kingdom | 14 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Proportion of Eyes With Acceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported.
Time frame: Up to 2-Week Follow-up
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Proportion of Eyes With Acceptable Lens Fitting | 100 Proportion of eyes |
| Senofilcon A | Proportion of Eyes With Acceptable Lens Fitting | 100 Proportion of eyes |