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

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: KL7016 900mg; Drug: Placebo; Drug: KL7016 600mg

• Registration Number: NCT02092207
• Lead Sponsor: Yungjin Pharm. Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KL7016 900mg	KL7016 900mg	-
Placebo	Placebo	-
KL7016 600mg	KL7016 600mg	-

Primary Outcome Measures

Name	Time	Method
Change in corneal staining score	baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in schirmer test score	baseline, 4weeks, 8weeks, 12 weeks
Change in OSDI(Ocular Surface Disease Index)	baseline, 4weeks, 8weeks, 12 weeks
Change in TFBUT(Tear Film Break-up Time)	baseline, 4weeks, 8weeks, 12 weeks
Change in conjunctival staining score	baseline, 4weeks, 8weeks, 12 weeks
Change in corneal staining score	baseline, 4weeks, 8weeks

Trial Locations

Locations (9)

Samsung Medical Center; 🇰🇷 Seoul, Irwon-ro, Gangnam-gu, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Jebong-ro, Dong-gu, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Banpo-daero, Seocho-gu, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Eonju-ro, Gangnam-gu, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Gurodong-ro, Guro-gu, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Neungdong-ro, Gwangjin-gu, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Yonsei-ro, Seodaemun-gu, Korea, Republic of

ASAN Medical Center; 🇰🇷 Seoul, Olympic-ro 43-gil, Songpa-gu, Korea, Republic of