Visual Acuity
Conditions
Brief summary
This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.
Interventions
DEVICETest Contact Lens
DEVICEControl Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be at least 18 and not more than 70 years of age (including 70). 4. The subject's refractive cylinder must be \< 0.75 Diopters (D) in each eye. 5. The subject must have best corrected visual acuity of 20/25 or better in each eye. 6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear). 7. The subject must have normal eyes (i.e., no ocular medications or infections of any type). 8. The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia. 5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) 6. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, 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 may contraindicate contact lens wear. 7. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution. 8. Any ocular infection. 9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 10. Monovision or multi-focal contact lens correction. 11. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 12. History of binocular vision abnormality or strabismus. 13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report). 14. Suspicion of or recent history of alcohol or substance abuse. 15. History of serious mental illness. 16. History of seizures. 17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Wearing Time | 2-week follow-up | Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens. |
| Visual Acuity (LogMAR) | 2-week Follow-up | Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported. |
Countries
United States
Participant flow
Pre-assignment details
A total of 142 subjects were enrolled into this study. Of the enrolled 1 subject did not meet the eligibility criteria and 141 were dispensed a study lens. Of the dispensed subjects 125 completed the study and 16 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least one study lens. | 141 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 1 |
| Period 1 | Protocol Violation | 0 | 1 |
| Period 1 | Torn Contact Len | 4 | 3 |
| Period 1 | Unsatisfactory Visual Response | 0 | 1 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
| Period 2 | Adverse Event | 1 | 1 |
| Period 2 | Lost Contact Lens | 0 | 1 |
| Period 2 | Torn Contact Lens | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 31.0 Years STANDARD_DEVIATION 8.96 |
| Race/Ethnicity, Customized Asian | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 111 Participants |
| Region of Enrollment North America | 141 Participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 141 | 0 / 141 |
| serious Total, serious adverse events | 0 / 141 | 0 / 141 |
Outcome results
Primary
Contact Lens Wearing Time
Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.
Time frame: 2-week follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) | Contact Lens Wearing Time | 14.55 Hours | Standard Deviation 1.534 |
| Senofilcon A (Control) | Contact Lens Wearing Time | 14.63 Hours | Standard Deviation 1.516 |
Primary
Visual Acuity (LogMAR)
Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.
Time frame: 2-week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A (Test) | Visual Acuity (LogMAR) | Dim High Contrast | 0.086 LogMAR | Standard Deviation 0.0874 |
| Senofilcon A (Test) | Visual Acuity (LogMAR) | Bright Low Contrast | 0.121 LogMAR | Standard Deviation 0.0905 |
| Senofilcon A (Control) | Visual Acuity (LogMAR) | Bright Low Contrast | 0.122 LogMAR | Standard Deviation 0.0881 |
| Senofilcon A (Control) | Visual Acuity (LogMAR) | Dim High Contrast | 0.089 LogMAR | Standard Deviation 0.0846 |