LME636 in the Relief of Persistent Ocular Discomfort in Patients With Severe Dry Eye Disease

This study is organized into 2 phases. Following a 2-week identification phase, eligible
subjects with severe dry eye disease (DED) will be randomized into the treatment phase and
will be dispensed study treatment for 10 weeks.

Inclusion Criteria:

- Must sign written informed consent.

- Physician diagnosis of DED of at least 6 months prior to Visit 1.

- Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis.

- Respond as "Often" or "constantly" to the question "how often do your eyes feel
uncomfortable?".

- Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS
at Visit 1.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Presence of any acute infection or non-infectious ocular condition in either eye
within 1 month of Visit 1.

- Contact lens wearers, defined as patients who cannot be without their contact lenses
for the entire duration of the study.

- Any chronic ocular degenerative condition that in the opinion of the Investigator
could possibly advance during the time course of the study.

- Use of biologics treatments, such as systemic biologic anticytokines, including
anti-TNF drugs, or immunosuppressive therapy for the treatment of severe systemic
autoimmune disorders.

- Diseases or conditions affecting the ocular surface that are associated with
clinically significant scarring and or destruction of conjunctiva and or cornea.

- Unwilling to abstain from topical ocular nonprescription medications during the
course of the study, including concomitant use of artificial tears, gels, lubricants,
re-wetting drops, allergy drops, etc. starting at Visit 2.

- Use of nasal, inhaled, systemic (including injections), or topical corticosteroids
within 30 days of Visit 1.

- Women of child-bearing potential unwilling to use effective contraception methods as
defined in the protocol.

- Other protocol-specified exclusion criteria may apply.