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This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control/Control | Experimental | Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day. |
|
| Control/Test/Test | Experimental | Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B+L Infuse spherical soft contact lenses | Device | Test lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit | Visual acuity (VA) will be collected for each eye at distance using Snellen charts at the fitting evaluation and after approximately 1-week of lens wear. | At 1-week follow-up per wear period |
| Proportion of Eyes with acceptable lens fit | Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each eye. | Up to 3-week follow-up |
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Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. 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. Be between 18 and 39 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
5. Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
6. Possess a wearable pair of spectacles that provide correction for distance vision.
7. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.
8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VisualEyes | Roswell | Georgia | 30076 | United States | ||
| New Bremen EyeCare |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| J&J ACUVUE OASYS 1-Day spherical soft contact lenses | Device | Control lens |
|
| New Bremen |
| Ohio |
| 45869 |
| United States |
| Botetourt Eyecare LLC | Salem | Virginia | 24153 | United States |
| New River Vision Care | Oak Hill | West Virginia | 25901 | United States |