Clinical trial NCT02092207: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: Yungjin Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in corneal staining score
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in schirmer test score
timeFrame: baseline, 4weeks, 8weeks, 12 weeks
measure: Change in OSDI(Ocular Surface Disease Index)
timeFrame: baseline, 4weeks, 8weeks, 12 weeks
measure: Change in TFBUT(Tear Film Break-up Time)
timeFrame: baseline, 4weeks, 8weeks, 12 weeks
measure: Change in conjunctival staining score
timeFrame: baseline, 4weeks, 8weeks, 12 weeks
measure: Change in corneal staining score
timeFrame: baseline, 4weeks, 8weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
state: Banpo-daero, Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Eonju-ro, Gangnam-gu
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gumi-ro 173 Beon-gil Bundang-gu
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Gurodong-ro, Guro-gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-ro, Gangnam-gu
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Jebong-ro, Dong-gu
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Neungdong-ro, Gwangjin-gu
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
state: Olympic-ro 43-gil, Songpa-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro, Seodaemun-gu
Study officials:
References: