Efficacy and Safety of HE10 for Dry Eye Syndrome
- Registration Number
- NCT02492412
- Lead Sponsor
- Huons Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.
- Detailed Description
This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
Inclusion Criteria
- Corneal staining score of ≥2(Oxford grade)
- Schirmer test score (without anesthesia) < 10 mm/5 min in either eye
- Tear break-up time is 10 seconds or less
- Screening both eyes, the corrected visual acuity is 0.2 or more
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
- History of eyeball surgical operation within 3 months of screening visit
- Wearing contact lenses within 2 weeks of screening visit
- Be a use or used punctual plug within 1 month of screening vist
- Use of cyclosporine eye drop within 3 weeks
- Pregnancy or Breastfeeding
- Intraocular pressure > 25 mmHg
- Abnormal eyelid function : Disorders of the eyelids or eyelashes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HE10 HE 10 Drug: HE10 1\~2 drops b.i.d at 12 hour interval for 12 weeks Restasis Restasis Drug: Restasis(Cyclosporine 0.05%) 1\~2 drops b.i.d at 12 hour interval for 12 weeks
- Primary Outcome Measures
Name Time Method Corneal staining Test to assess eye dryness 12 weeks Change from baseline in eye dryness at 12 weeks
- Secondary Outcome Measures
Name Time Method