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Efficacy and Safety of HE10 for Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HE 10
Restasis
Sponsored by
Huons Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HE10

    Restasis

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Corneal staining Test to assess eye dryness
    Change from baseline in eye dryness at 12 weeks

    Secondary Outcome Measures

    Full Information

    First Posted
    June 25, 2015
    Last Updated
    July 5, 2015
    Sponsor
    Huons Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02492412
    Brief Title
    Efficacy and Safety of HE10 for Dry Eye Syndrome
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Huons Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HE10
    Arm Type
    Experimental
    Arm Description
    Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks
    Arm Title
    Restasis
    Arm Type
    Active Comparator
    Arm Description
    Drug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    HE 10
    Intervention Type
    Drug
    Intervention Name(s)
    Restasis
    Other Intervention Name(s)
    0.05% cyclosporine
    Primary Outcome Measure Information:
    Title
    Corneal staining Test to assess eye dryness
    Description
    Change from baseline in eye dryness at 12 weeks
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of HE10 for Dry Eye Syndrome

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