Biomarker Discovery in Two Daily Disposable Contact Lenses

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.
• Appear able and willing to adhere to a no lens wear period of at least one month.
• Between 18 and 45 (inclusive) years of age at the time of screening.
• Subject must be currently wearing one of the two habitual contact lenses in both eyes (1DAM or DACP) for at least three months. Habitual CL wear is defined as having a minimum wearing time of 3 hours per day, minimum of 3 days per week for at least 3 months.
• Subject must have visual acuity of at least 20/40 or better in each eye with their habitual lenses
• Subjects must meet one of the following criteria in order to be classified as either asymptomatic or symptomatic group:

• Asymptomatic group: CLDEQ-8 score of ≤7, difference between CWT and AWT <1 hours/day
• Symptomatic group: CLDEQ-8 score of ≥15, difference between CWT and AWT >3 hours/day
• Have healthy eyes with no evidence of abnormality or disease (i.e., no active ocular pathological conditions/ infections of any type).
• Have a pair of spectacles that provide corrected binocular visual acuity of 20/40 or better. If no spectacles, subjects must have un-aided binocular visual acuity of 20/40 or better.

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.
• Unacceptable lens fit with their habitual lenses in either eye based on study investigators judgment.
• Any extended wear modality.
• Use of systemic medications (e.g., chronic steroid use, immuno-suppressants or anti-infective medications) that are known to interfere with contact lens wear.
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
• Any previous, or planned (during the course of the study) intraocular/refractive surgery.
• Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
• Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear.
• Participation in any interventional contact lens, eye drop or lens care product clinical trial within 30 days prior to study enrollment.
• Suspicion of or recent history of alcohol or substance abuse, serious mental illness, or seizures.
• Employee of clinical site (e.g., Investigator, Coordinator, Technician).