NCT02492412
Completed
Phase 3
Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome
Overview
- Phase
- Phase 3
- Intervention
- HE 10
- Conditions
- Dry Eye Syndrome
- Sponsor
- Huons Co., Ltd.
- Enrollment
- 101
- Primary Endpoint
- Corneal staining Test to assess eye dryness
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
HE10
Drug: HE10 1\~2 drops b.i.d at 12 hour interval for 12 weeks
Intervention: HE 10
Restasis
Drug: Restasis(Cyclosporine 0.05%) 1\~2 drops b.i.d at 12 hour interval for 12 weeks
Intervention: Restasis
Outcomes
Primary Outcomes
Corneal staining Test to assess eye dryness
Time Frame: 12 weeks
Change from baseline in eye dryness at 12 weeks
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