NCT02092207

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

March 17, 2014

Last Update Submit

December 19, 2017

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in corneal staining score

    baseline, 12 weeks

Secondary Outcomes (5)

  • 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

Study Arms (3)

KL7016 900mg

EXPERIMENTAL
Drug: KL7016 900mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

KL7016 600mg

EXPERIMENTAL
Drug: KL7016 600mg

Interventions

KL7016 900mgDRUG

oral administration, 150mg 3tab, bid

KL7016 900mg
KL7016 600mgDRUG

oral administration, 150mg 3tab, bid

KL7016 600mg
PlaceboDRUG

oral administration, 150mg 3tab, bid

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Banpo-daero, Seocho-gu, 137-701, South Korea

Location

Gangnam Severance Hospital

Seoul, Eonju-ro, Gangnam-gu, 135-720, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, 463-707, South Korea

Location

Korea University Guro Hospital

Seoul, Gurodong-ro, Guro-gu, 152-703, South Korea

Location

Samsung Medical Center

Seoul, Irwon-ro, Gangnam-gu, 135-710, South Korea

Location

Chonnam National University Hospital

Gwangju, Jebong-ro, Dong-gu, 501-757, South Korea

Location

Konkuk University Medical Center

Seoul, Neungdong-ro, Gwangjin-gu, 143-729, South Korea

Location

ASAN Medical Center

Seoul, Olympic-ro 43-gil, Songpa-gu, 138-736, South Korea

Location

Severance Hospital

Seoul, Yonsei-ro, Seodaemun-gu, 120-752, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

December 21, 2017

Record last verified: 2017-12

Locations

KR(9)