Trial | NCT02492412  Report issue

Title

Efficacy and Safety of HE10 for Dry Eye Syndrome
Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    101
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.
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.
Study Started
May 31
2013
Primary Completion
Jul 31
2014
Study Completion
Sep 30
2014
Last Update
Jul 08
2015
Estimate

Drug HE 10

Drug Restasis

  • Other names: 0.05% cyclosporine

HE10 Experimental

Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks

Restasis Active Comparator

Drug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks

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
No Results Posted