Dry Eye Disease
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 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 in at least one of both eyes * Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit * Best corrected visual acuity of 0.2 or higher in both eyes * Those who voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion criteria
* Patients with clinically significant ocular disorders affected the test result * Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c \> 9% * Wearing contact lenses within 72 hr prior to screening visit or during clinical trial * Pregnancy or Breastfeeding * Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes * Patient with autoimmune disease (e.g. sjogren's syndrome) * Patients with a history of corneal transplant or neurotrophic keratitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corneal staining score | 12weeks | Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline \- Oxford grading: 0(Absent) to 5(Severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in conjuctival staining score | 4, 8, 12weeks | Change in conjuctival staining score assessed on Oxford grading at 4, 8, 12 weeks compared to baseline |
| Change from baseline in strip meniscometry score | 4, 8, 12weeks | Change in strip meniscometry score at 4, 8, 12 weeks compared to baseline |
| Change from baseline in corneal staining score | 4, 8weeks | Change in corneal staining score assessed on Oxford grading at 4, 8 weeks compared to baseline |
| Change from baseline in SPEED dry eye questionnaire score | 4, 8, 12weeks | Change in SPEED dry eye questionnaire score at 4, 8, 12 weeks compared to baseline |
| Time to achieve 100% clearance in corneal staining | 12weeks | Time to achieve 100% clearance in corneal staining up to 12 weeks |
| Change from baseline in TBUT score | 4, 8, 12weeks | Change in TBUT score at 4, 8, 12 weeks compared to baseline |
Countries
South Korea
Outcome results
None listed