Dry Eye Syndrome
Conditions
Brief summary
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome
Interventions
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age over 19 * Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) * Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception
Exclusion criteria
* The patients with systemic or ocular disorders affected the test result * Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * Being treated with systemic steroid * Wearing contact lenses within 72 hr of screening visit * Pregnancy or Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from Baseline in Corneal staining(Oxford grading) score | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| change from Baseline of Conjunctival staining(Oxford grading) score | Week 4,8,12 |
| change from Baseline of Strip meniscometry assessment | Week 4,8,12 |
| change from Baseline of Tear film break-up time | Week 4,8,12 |
| change from Baseline in Corneal staining(Oxford grading) score | Week 4,8 |
| arrival time of 100% clearence in Corneal staining test | Week 0-12 |
| The number of total rescue drug usage | Week 0-12 |
| change from Baseline of Standard patient evaluation of eye dryness questionnaire | Week 4,8,12 |
Countries
South Korea
Outcome results
None listed