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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KL7016 900mg
KL7016 600mg
Placebo
Sponsored by
Yungjin Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Gangnam Severance Hospital
  • Seoul National University Bundang Hospital
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Chonnam National University Hospital
  • Konkuk University Medical Center
  • ASAN Medical Center
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

KL7016 900mg

Placebo

KL7016 600mg

Arm Description

Outcomes

Primary Outcome Measures

Change in corneal staining score

Secondary Outcome Measures

Change in schirmer test score
Change in OSDI(Ocular Surface Disease Index)
Change in TFBUT(Tear Film Break-up Time)
Change in conjunctival staining score
Change in corneal staining score

Full Information

First Posted
March 17, 2014
Last Updated
December 19, 2017
Sponsor
Yungjin Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02092207
Brief Title
Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yungjin Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KL7016 900mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
KL7016 600mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KL7016 900mg
Intervention Description
oral administration, 150mg 3tab, bid
Intervention Type
Drug
Intervention Name(s)
KL7016 600mg
Intervention Description
oral administration, 150mg 3tab, bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration, 150mg 3tab, bid
Primary Outcome Measure Information:
Title
Change in corneal staining score
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in schirmer test score
Time Frame
baseline, 4weeks, 8weeks, 12 weeks
Title
Change in OSDI(Ocular Surface Disease Index)
Time Frame
baseline, 4weeks, 8weeks, 12 weeks
Title
Change in TFBUT(Tear Film Break-up Time)
Time Frame
baseline, 4weeks, 8weeks, 12 weeks
Title
Change in conjunctival staining score
Time Frame
baseline, 4weeks, 8weeks, 12 weeks
Title
Change in corneal staining score
Time Frame
baseline, 4weeks, 8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
State/Province
Banpo-daero, Seocho-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Eonju-ro, Gangnam-gu
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
State/Province
Gumi-ro 173 Beon-gil Bundang-gu
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Gurodong-ro, Guro-gu
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Irwon-ro, Gangnam-gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Jebong-ro, Dong-gu
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Neungdong-ro, Gwangjin-gu
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
ASAN Medical Center
City
Seoul
State/Province
Olympic-ro 43-gil, Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
State/Province
Yonsei-ro, Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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