A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)

A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca

This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.

Inclusion Criteria:

• No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
• Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
• Corrected Snellen acuity of 20/40 or better in both eyes

Exclusion Criteria:

• Subjects diagnosed with any ocular disease other than refraction error
• Subjects with intraocular pressure >21 mmHg
• Use of a contact lens within 7 days prior to administration of the first dose
• Subjects with history of ocular surgery
• Subjects with a history of laser refractive surgery