Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 4)

Inclusion criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be between 18 and 45 years of age (inclusive) at the time of screening
• They have worn the same brand of soft contact lenses for at least the previous three months.
• They agree not to participate in other clinical research trials for the duration of this study.
• In a pre-study screening assessment, they must have a CLDEQ-8 score of 10 or less (asymptomatic group) or 20 or higher (symptomatic group).
• They possess a wearable pair of distance glasses and agree to bring these to the study visit (if needed for distance vision correction).
• They can attain a high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses.
• Their habitual contact lenses fit satisfactorily.

Exclusion criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

• Currently pregnant or lactating
• Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
• They have an ocular disorder which would normally contraindicate contact lens wear.
• 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 have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
• They are 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.
• History of allergic reaction to sodium fluorescein or topical anesthetic.
• Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• 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.