Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase II Clinical Study to Evaluate the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).

Inclusion Criteria:

• Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines
• Schirmer test score (without anesthesia) < 7 mm/5 min in either eye
• Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial

Exclusion Criteria:

• Intraocular surgery within 3months
• Persistent intraocular inflammation or infection
• Corneal transplantation or neurotrophic keratitis
• Stevens-Johnson Syndrome
• Ocular herpes simplex virus infection
• Concomitant use of contact lenses or use within 3months
• Silicone lacrimal punctal occlusion or cauterization of the punctum within 3months
• Vision correction surgery without DES within 12months
• Unstable use of methotrexate or Disease-modifying drugs