Tear Lipid Layer Thickness With Emollient Eye Drops

This study will objectively evaluate two US Monograph lubricant eyedrop formulations
(Allergan, plc). Refresh Optive ADVANCED will be compared to an investigational formula with
additional compendial ingredients (Refresh Optive MEGA 3) in subjects with dry eye symptoms
and lipid layer thickness < 65 nm at baseline in a randomized, cross-over (masked subject)
design. We seek to objectively evaluate the increase in lipid layer thickness from baseline
at 15 minutes and 1, 2 and 4 hours after each eye drop has been instilled. The Stroboscopic
Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness
measurement.

Inclusion Criteria:

- Age - at least 30 years

- Good general health (defined by medication use that has not changed within the
last month and the absence of medical conditions or treatments that are deemed
confounding to the data as determined by the PI)

- Ability to give informed consent

- Willing to spend time for the study; approximately one hour for a screening visit
and additional 4 hours for the study assessments. Study assessment will be
conducted over 2 visit days, approximately 5 hours per day.

- Either gender

- Any racial or ethnic origin

- Stroboscopic Video Color Microscope tear lipid thickness ≤ 65 nm

Exclusion Criteria:

- Use of any ocular prescription medication (such as but not limited to, glaucoma
medications, anti-inflammatory eye drops and Restasis) used within 14 days of the
screening visit or started prior to the measurement visit(s).

- Currently having punctal plugs inserted in lacrimal puncta

- Current eye disease, infection or inflammation that affects the surface of the
eye such as, but not limited to moderate or greater blepharitis and ocular
allergy. Clinically significant (active treatment) of blepharitis, Sjogren's
disease or other systemic disease that could influence Meibomian Gland
Dysfunction, corneal, conjunctival, or eyelid abnormalities that could influence
lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic
medication such as diuretics or drugs that could influence tear secretion, or
sensitivity to any of the ingredient in the eye drop being tested,

- Past eye surgery, such as, but not limited to, refractive surgery. Subjects who
have had cataract removal surgery more than one year ago, but less than 10 years
ago may be considered as potential subjects.

- Female subjects may not be pregnant or lactating. (Subject will be asked to self
report these conditions.)

- Infectious diseases (for example, hepatitis, tuberculosis) or an
immuno-suppressive disease (for example, HIV). (Subjects will be asked to
self-report these conditions.)

- Inability to complete the screening and examination

- Inability to provide analyzable data. For example, subjects who cannot keep their
eye open during the entire measurement interval (due to early blinking) or
provide a readable eye image (due to eyelid laxity) or cannot sit still for 1
minute.