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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KT&G Life Sciences Corp; Yungjin Pharm. Co., Ltd.

Criteria

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