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In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE® Gel Drop lubricant eye gel
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye, Epithelial changes

Eligibility Criteria

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

Inclusion Criteria:

Subjects must have history of dry eye as determined by:

  1. Questionnaire
  2. Tear Film Break Up Time less than or equal to 10 seconds
  3. Schirmer's score of less than or equal to 5 mm
  4. Corneal staining greater than or equal to 3 in either eye, and
  5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion Criteria:

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SYSTANE® Gel Drops Lubricant eye gel

    Arm Description

    SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

    Outcomes

    Primary Outcome Measures

    Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
    The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2011
    Last Updated
    November 17, 2016
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01483989
    Brief Title
    In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients
    Official Title
    In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
    Detailed Description
    The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SYSTANE® Gel Drops Lubricant eye gel
    Arm Type
    Experimental
    Arm Description
    SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
    Intervention Type
    Other
    Intervention Name(s)
    SYSTANE® Gel Drop lubricant eye gel
    Other Intervention Name(s)
    Systane Gel
    Intervention Description
    SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
    Primary Outcome Measure Information:
    Title
    Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
    Description
    The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
    Time Frame
    baseline and 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must have history of dry eye as determined by: Questionnaire Tear Film Break Up Time less than or equal to 10 seconds Schirmer's score of less than or equal to 5 mm Corneal staining greater than or equal to 3 in either eye, and Positive for conjunctival staining (greater than or equal to 1) Exclusion Criteria: Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

    12. IPD Sharing Statement

    Citations:
    Citation
    http://iovs.arvojournals.org/article.aspx?articleid=2351788
    Results Reference
    result

    Learn more about this trial

    In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

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