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

Yungjin Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: KL7016 600mg; Drug: Placebo; Drug: KL7016 900mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02092207

KL7016_201

Details and patient eligibility

About

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

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 3 patient groups, including a placebo group

KL7016 900mg

Experimental group

Treatment:

Drug: KL7016 900mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

KL7016 600mg

Experimental group

Treatment:

Drug: KL7016 600mg