Clinical Performance of Two Daily Disposable Silicone Hydrogel 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.
• Between 18 and 40 (inclusive) years of age at the time of screening.
• They agree not to participate in other clinical research while enrolled on this study.
• They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.
• They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
• They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
• They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).
• They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).

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 or may pose a risk to study personnel.
• They have an ocular disorder which would normally contraindicate contact lens wear.
• They have had cataract surgery.
• They have had corneal refractive surgery.
• They are using any topical medications such as eye drops or ointments.
• Any known hypersensitivity or allergic reaction to sodium fluorescein.
• Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
• Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 13. They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.