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This is a subject-masked, randomized, prospective, bilateral, 3x3 crossover dispensing clinical investigation to assess the clinical performance of a new lens type comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens 1/Test Lens 2/Test Lens 3 | Experimental | Eligible subjects will be randomized into the Test Lens 1/Test Lens 2/Test Lens 3 sequence, to wear each lens for up to 10 hours each. |
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| Test Lens 1/Test Lens 3/Test Lens 2 | Experimental | Eligible subjects will be randomized into the Test Lens 1/Test Lens 3/Test Lens 2 sequence, to wear each lens for up to 10 hours each. |
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| Test Lens 2/Test Lens 1/Test Lens 3 | Experimental | Eligible subjects will be randomized into the Test Lens 2/Test Lens 1/Test Lens 3 sequence, to wear each lens for up to 10 hours each. |
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| Test Lens 2/Test Lens 3/Test Lens 1 | Experimental | Eligible subjects will be randomized into the Test Lens 2/Test Lens 3/Test Lens 1 sequence, to wear each lens for up to 10 hours each. |
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| Test Lens 3/Test Lens 1/Test Lens 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens 1 | Device | Acuvue® Oasys MAX 1-Day daily disposable contact lenses |
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| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit Acceptance | Lens Fit Acceptance: Lens fit acceptance will be assessed at dispensing and follow-up visits for each subject eye. An unacceptable fit is deemed by one or more of the following criteria:
| Follow-up assessments will be made approximately 8-10 hours after lens dispensing |
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Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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 |
|---|---|---|---|---|---|---|
| The University of Manchester, Department of Optometry & Neuroscience | Manchester | M13 9PL | United Kingdom |
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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Eligible subjects will be randomized into the Test Lens 3/Test Lens 1/Test Lens 2 sequence, to wear each lens for up to 10 hours each. |
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| Test Lens 3/Test Lens 2/Test Lens 1 | Experimental | Eligible subjects will be randomized into the Test Lens 3/Test Lens 2/Test Lens 1 sequence, to wear each lens for up to 10 hours each. |
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| Test Lens 2 | Device | Dailies Total 1 daily disposable contact lenses |
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| Test Lens 3 | Device | Clariti 1-Day daily disposable contact lenses |
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