Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops

This study will objectively evaluate two US lubricant eye drop formulations produced by
Alcon, INC. Systane® Ultra, a non-emollient eye drop, will be compared to Systane® Complete,
an emollient eye drop, in subjects with dry eye symptoms and lipid layer thickness < 75 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, 4 and 6 hours
after each eye drop has been instilled. Non-invasive measurements of tear break-up time will
be also conducted at each visit. Subjects will then be dispensed the emollient eye drop
(Systane® Complete) for use four times daily for one month and return to the study site for
final measurements of dry eye symptoms, lipid layer thickness, and tear break-up time. The
Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer
thickness measurement, and the Oculus Keratograph (K5M) is used for non-invasive measurements
of tear break-up time.

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
two eye drop exposure visits lasting approximately 6 hours each. Part 2 of the study
will include using an eye drop of Systane® Complete 4x/day for 1 month and returning
for one visit lasting approximately 1 hour.

- Either gender

- Any racial or ethnic origin

- SVCM tear lipid thickness ≤ 75 nm

- Contact lens wearers must refrain from lens wear for two days before the screening
visit, including the day of the baseline visit, and during the entire study.

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 MGD, corneal, conjunctival, or eyelid
abnormalities that could influence lipid layer thickness, conjunctivitis of any cause,
ocular infection or systemic medication such as diuretics, SSRIs, 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 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.