Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
NCT ID: NCT02092207
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2012-10-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
KL7016 900mg
KL7016 900mg
oral administration, 150mg 3tab, bid
Placebo
Placebo
oral administration, 150mg 3tab, bid
KL7016 600mg
KL7016 600mg
oral administration, 150mg 3tab, bid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KL7016 900mg
oral administration, 150mg 3tab, bid
KL7016 600mg
oral administration, 150mg 3tab, bid
Placebo
oral administration, 150mg 3tab, bid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yungjin Pharm. Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Banpo-daero, Seocho-gu, South Korea
Gangnam Severance Hospital
Seoul, Eonju-ro, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, South Korea
Korea University Guro Hospital
Seoul, Gurodong-ro, Guro-gu, South Korea
Samsung Medical Center
Seoul, Irwon-ro, Gangnam-gu, South Korea
Chonnam National University Hospital
Gwangju, Jebong-ro, Dong-gu, South Korea
Konkuk University Medical Center
Seoul, Neungdong-ro, Gwangjin-gu, South Korea
ASAN Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, South Korea
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KL7016_201
Identifier Type: -
Identifier Source: org_study_id