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This is a single arm, prospective, bilateral, non-randomized study that will be split into four elements. Element 1 will be an in vitro non-clinical study and described in the laboratory protocol. Elements 2, 3 and 4 will each be a single non-dispensing visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Element 2 | Four clinical samples will be taken from each eligible subject and used to assess two clinical removal methods and two in vitro removal methods. | ||
| Element 3 | Four clinical samples will be taken from each eligible subject and used to assess three different storage methods. | ||
| Element 4 | Four clinical samples will be taken from each eligible subject and used to assess different ocular regions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Cells | The frequency count of cells will be summarized within the category. | 1.5 hours duration of assessment time |
| Types of Cells | The percentage of types of cells will be summarized within the category. | 1.5 hours duration of assessment time |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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Eligible subjects aged 18 years and above with normal healthy eyes will be recruited for this work.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | 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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ocular surface cells