Visual Acuity
Conditions
Brief summary
This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.
Interventions
DEVICEsenofilcon A
ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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. Must be at least 60 years of age at the time of screening. 4. The subject must have normal eyes (i.e., no ocular medications or infections of any type). 5. The subject must have best corrected visual acuity (BCVA) of 20/30 or better in each eye.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. A habitual and adapted wearer of contact lenses (have worn a contact lens at least one time in the past 5 years). 2. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. 4. Any ocular infection. 5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 7. History of binocular vision abnormality or strabismus. 8. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report). 9. Suspicion of or recent history of alcohol or substance abuse. 10. History of serious mental illness. 11. History of seizures. 12. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician) 13. 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 14. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale 15. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success Rate of Insertion and Removal of a Contact Lens | Lens insertion and Removal, up to 2-Hours | The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded. |
Countries
United States
Participant flow
Recruitment details
A total of 16 subjects were enrolled into this study. Of those enrolled, 2 failed to meet all eligibility criteria. Of 14 dispensed subjects all completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed a study lens. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 65.3 Years STANDARD_DEVIATION 2.37 |
| Race/Ethnicity, Customized White | 14 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Overall Success Rate of Insertion and Removal of a Contact Lens
The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.
Time frame: Lens insertion and Removal, up to 2-Hours
Population: All subjects who successfully ompleted all study visits and did not substanially deviate from the protocol as deterined by the trial cohort review committee prior to database lock.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A | Overall Success Rate of Insertion and Removal of a Contact Lens | 85.7 Percentage of eyes |