The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x
magnification, using a scanning laser. The laser is used to map the cornea, and will not
damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and
nerves within the cornea, providing a better understanding of how the cornea reacts to
irritants. IVCM has recently been used by the investigator to assess the extent of eye
inflammation in cases of dry eye patients.

Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse
therapy, administered twice daily (to avoid adverse effects associated with long-term steroid
use). This time frame is often too short to meaningfully resolve the inflammation associated
with DED. DED often occurs when there is a decrease in the eye's tear production or if there
is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye
moist). Eye irritation and inflammation (swelling) is often associated with DED because the
surface of the eye is unable to maintain a normal level of moisture.

Inclusion Criteria:

- Age 18-89 years.

- Willing and able to provide written informed consent.

- Willing and able to comply with study assessments for the full duration of the study.

- In good stable overall health.

- Corneal dendritiform cell count by confocal microscopy of >=75/mm2 (13 immune cells
per image)

- Diagnosis of dry eye disease based on the followings:

- Symptoms of dry eye disease such as foreign body sensation, burning, stinging, light
sensitivity for at least 6 months.

- Two or more of the following objective signs:

- Schirmer test with anesthesia <10 mm at 5 minutes [mean Schirmer between eyes.

- Tear break-up time (TBUT) of <10 seconds.

- Corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye

- Lissamine green staining of the nasal and temporal conjunctiva (NEI grading scheme,
0-18) in at least one eye

Exclusion Criteria:

- Central corneal subbasal dendritic cell count by in vivo confocal microscopy of
<75/mm2 in both eyes

- Active ocular allergies

- Active allergies to steroids, aminoglycosides, or benzalkonium chloride (BAK)

- History of contact lens wear within 3 months before enrollment.

- Intraocular surgery or ocular laser surgery within 3 months before enrollment.

- History of ocular infection within 3 months before enrollment.

- History of topical (for ophthalmic use) or systemic steroid treatment (Loteprednol
(other than Lotemax suspension used in our study), Difluprednate, Fluorometholone,
Prednisolone, Dexamethasone, Triamcinolone, Rimexolone, Medrysone) within 1 month
before enrollment. In case of topical ophthalmic steroid use, a wash-out period of 1
month is required.

- History of increased intraocular pressure after using topical steroids (steroid
responsive)

- Change in systemic immunosuppression medication in the past 3 months.

- History of any change in the frequency of topical cyclosporine or oral tetracycline
compounds (tetracycline, doxycycline, and minocycline) within 1 month before
enrollment.

- Any condition (including language barrier) that precludes subject's ability to comply
with study requirements including completion of study.