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Efficacy and Safety of HE10 for Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02492412
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: HE 10 Drug: Restasis Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome
Study Start Date : May 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HE10
Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks
Drug: HE 10
Active Comparator: Restasis
Drug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks
Drug: Restasis
Other Name: 0.05% cyclosporine

Primary Outcome Measures :
  1. Corneal staining Test to assess eye dryness [ Time Frame: 12 weeks ]
    Change from baseline in eye dryness at 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Huons Co., Ltd. Identifier: NCT02492412     History of Changes
Other Study ID Numbers: Huons
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Pathologic Processes
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors