Dry Eye Syndrome
Conditions
Brief summary
A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome
Interventions
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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 * Volunteer who has negative result of pregnancy test or use effective contraception
Exclusion criteria
* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * The patients with systemic or ocular disorders affected the test result * Being treated with systemic steroid * Wearing contact lenses within 3 days of screening visit * Pregnancy or Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from Baseline of Corneal staining score - Oxford grading | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| change from Baseline of Corneal staining score - Oxford grading | Week 4, 8 |
| 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 of Standard patient evaluation of eye dryness questionnaire | Week 4, 8, 12 |
Countries
South Korea
Outcome results
None listed