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

December 19, 2017 updated by: Yungjin Pharm. Co., Ltd.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Banpo-daero, Seocho-gu
      • Seoul, Banpo-daero, Seocho-gu, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Eonju-ro, Gangnam-gu
      • Seoul, Eonju-ro, Gangnam-gu, Korea, Republic of, 135-720
        • Gangnam Severance Hospital
    • Gumi-ro 173 Beon-gil Bundang-gu
      • Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Gurodong-ro, Guro-gu
      • Seoul, Gurodong-ro, Guro-gu, Korea, Republic of, 152-703
        • Korea University Guro Hospital
    • Irwon-ro, Gangnam-gu
      • Seoul, Irwon-ro, Gangnam-gu, Korea, Republic of, 135-710
        • Samsung Medical Center
    • Jebong-ro, Dong-gu
      • Gwangju, Jebong-ro, Dong-gu, Korea, Republic of, 501-757
        • Chonnam National University Hospital
    • Neungdong-ro, Gwangjin-gu
      • Seoul, Neungdong-ro, Gwangjin-gu, Korea, Republic of, 143-729
        • Konkuk University Medical Center
    • Olympic-ro 43-gil, Songpa-gu
      • Seoul, Olympic-ro 43-gil, Songpa-gu, Korea, Republic of, 138-736
        • Asan Medical Center
    • Yonsei-ro, Seodaemun-gu
      • Seoul, Yonsei-ro, Seodaemun-gu, Korea, Republic of, 120-752
        • Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in corneal staining score
Time Frame: baseline, 12 weeks
baseline, 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yungjin Pharm. Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Actual)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KL7016_201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndrome

Clinical Trials on KL7016 900mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe