Assessment of Intracellular Cytokines and Markers in Cells (Phase 3)

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 3)

Conditions
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Impression Cytology

Participation Criteria
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Eligibility Criteria
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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: They have had cataract surgery. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or breast-feeding. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history or anaphylaxis or severe allergic reactions. They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study. They are currently regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications. They are using any topical medications such as eye drops or ointments. They are a current (i.e. within the last three months) contact lens wearer (wearing a lens in one or both eyes). History of allergic reaction to sodium fluorescein or topical anesthetic. They have Grade 3 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining (white light evaluation), tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. Any active ocular infection or inflammation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Element 2<br>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<br>Four clinical samples will be taken from each eligible subject and used to assess three different storage methods. | |
| Element 4<br>Four clinical samples will be taken from each eligible subject and used to assess different ocular regions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |