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

A Randomized, Double-masked, Vehicle-controlled Study of LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease

The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when administered topically for up to 42 days, in subjects 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 individuals 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 anti-cytokines, including anti-TNFα 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 non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc. after 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.