Dry Eye Syndrome
Conditions
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).
Interventions
DRUGKL7016 900mg
oral administration, 150mg 3tab, bid
DRUGKL7016 600mg
oral administration, 150mg 3tab, bid
DRUGPlacebo
oral administration, 150mg 3tab, bid
Sponsors
Yungjin Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in corneal staining score | baseline, 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed