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

Sponsor

Yungjin Pharm. Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02092207

Collaborator

(none)

147

Enrollment

Locations

Arms

Duration (Months)

16.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: KL7016 900mg Drug: KL7016 600mg Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KL7016 900mg	Drug: KL7016 900mg oral administration, 150mg 3tab, bid
Placebo Comparator: Placebo	Drug: Placebo oral administration, 150mg 3tab, bid
Experimental: KL7016 600mg	Drug: KL7016 600mg oral administration, 150mg 3tab, bid

Arm

Intervention/Treatment

Experimental: KL7016 900mg

Drug: KL7016 900mg

oral administration, 150mg 3tab, bid

Placebo Comparator: Placebo

Drug: Placebo

oral administration, 150mg 3tab, bid

Experimental: KL7016 600mg

Drug: KL7016 600mg

oral administration, 150mg 3tab, bid

Outcome Measures

Primary Outcome Measures

Change in corneal staining score [baseline, 12 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	Banpo-daero, Seocho-gu	Korea, Republic of	137-701
2	Gangnam Severance Hospital	Seoul	Eonju-ro, Gangnam-gu	Korea, Republic of	135-720
3	Seoul National University Bundang Hospital	Gyeonggi-do	Gumi-ro 173 Beon-gil Bundang-gu	Korea, Republic of	463-707
4	Korea University Guro Hospital	Seoul	Gurodong-ro, Guro-gu	Korea, Republic of	152-703
5	Samsung Medical Center	Seoul	Irwon-ro, Gangnam-gu	Korea, Republic of	135-710
6	Chonnam National University Hospital	Gwangju	Jebong-ro, Dong-gu	Korea, Republic of	501-757
7	Konkuk University Medical Center	Seoul	Neungdong-ro, Gwangjin-gu	Korea, Republic of	143-729
8	ASAN Medical Center	Seoul	Olympic-ro 43-gil, Songpa-gu	Korea, Republic of	138-736
9	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu	Korea, Republic of	120-752

Sponsors and Collaborators

Yungjin Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yungjin Pharm. Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02092207

Other Study ID Numbers:

KL7016_201

First Posted:

Mar 20, 2014

Last Update Posted:

Dec 21, 2017

Last Verified:

Dec 1, 2017

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Syndrome

Study Results

No Results Posted as of Dec 21, 2017